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Week of Jun 16, 2025

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Jun 18, 2025recall421d agoMacleods Pharmaceuticals Ltd recall (Cls III)Telix Pharmaceuticals Ltd

Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44. — Reason: Presence of a foreign substance: black hair found embedded in tablet. — Status: Ongoing

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Jun 18, 2025recall421d agoGlenmark Pharmaceuticals Inc., USA recall (Cls III)LB PHARMACEUTICALS INC

Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90 — Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study. — Status: Ongoing

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Jun 18, 2025device pma421d agoMedtronic, Inc. — SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

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Jun 18, 2025device pma421d agoMedtronic, Inc. — MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoABBOTT MEDICAL — P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256, (PMA supplement)

Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoBiotronik, Inc. — Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- (PMA supplement)

Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoMedtronic, Inc. — Aurora EV-ICD System (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

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Jun 18, 2025device pma421d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

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Jun 18, 2025device pma421d agoABBOTT MEDICAL — Endurity MRI PM1172, PM2172; Assurity MRI PM1272, PM2272; Zenex MRI PM1282, PM2282; Zenus MRI PM1182, PM2182; Accent MRI (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoABBOTT MEDICAL — Aveir LSP112V, LSP201A, LSP202V (PMA supplement)

Supplement type: 30-Day Notice. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoSeikagaku Corp. — Gel-One (PMA supplement)Seikagaku Corp

Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30

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Jun 18, 2025device pma421d agoEBR Systems, Inc. — WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (PMA supplement)EBR Systems, Inc.

Supplement type: Normal 180 Day Track No User Fee. Product code: SEG. Advisory committee: CV. Decision: APPR

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Jun 18, 2025device pma421d agoAlcon Research, Ltd. — AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (PMA supplement)Rubicon Research Ltd

Supplement type: Normal 180 Day Track No User Fee. Product code: MFK. Advisory committee: OP. Decision: APPR

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Jun 18, 2025device pma421d agoAlcon Laboratories, LLC — Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses (PMA supplement)Alcon Laboratories Inc

Supplement type: Normal 180 Day Track No User Fee. Product code: HQL. Advisory committee: OP. Decision: APPR

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Jun 18, 2025device pma421d agoABBOTT MEDICAL — Allure PM3120; Allure Quadra RF PM3242; Allure Quadra PM3140; Allure RF PM3222; Anthem PM3210; Quadra Allure PM3542; (PMA supplement)

Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoABBOTT MEDICAL — IsoFlex Optim Lead 1944, 1948 (PMA supplement)

Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoMedtronic Neuromodulation — Restore, Itrel®, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify®, and Vect (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

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Jun 18, 2025device pma421d agoNeomend, Inc. — TRIDYNE Vascular Sealant (PMA supplement)

Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoMentor Corp. — MENTOR MemoryGel Enhance Breast Implants (PMA supplement)

Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

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Jun 18, 2025device pma421d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoInfusyn Therapeutics, LLC — PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (PMA supplement)LIB Therapeutics LLC

Supplement type: Normal 180 Day Track No User Fee. Product code: LKK. Advisory committee: HO. Decision: APPR

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Jun 18, 2025device pma421d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoABBOTT MEDICAL — Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210, (PMA supplement)

Supplement type: 30-Day Notice. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoCerapedics, Inc. — PearlMatrix Bone Graft (PMA)

Product code: NOX. Advisory committee: OR. Decision: APPR

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Jun 18, 2025device pma421d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Bra (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoMedtronic, Inc. — Micra AV TPS MC1AVR1, Micra AV2 TPS MC2AVR1, Micra TPS MC1VR01, Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoABBOTT MEDICAL — OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead (PMA supplement)

Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoABBOTT MEDICAL — Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoInspire Medical Systems — Inspire® Upper Airway Stimulation (UAS) (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

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Jun 18, 2025device pma421d agoBiotronik, Inc. — Edora 8 HF-T QP 407137, Edora 8 HF-T 407138, Evity 8 HF-T QP 407139, Evity 8 HF-T 407140, Enitra 8 HF-T QP 407141, Enitr (PMA supplement)

Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoMedtronic, Inc. — SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoABBOTT MEDICAL — Gallant DR CDDRA500Q; Gallant VR CDVRA500Q; Neutrino NxT DR CDDRA800Q; Neutrino NxT DR CDDRA600Q; Neutrino NxT VR CDVRA8 (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoMedtronic, Inc. — Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02; Ser (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoIntersect Ent. — PROPEL, PROPEL MINI and PROPEL CONTOUR (PMA supplement)

Supplement type: 30-Day Notice. Product code: OWO. Advisory committee: EN. Decision: OK30

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Jun 18, 2025device pma421d agoBausch & Lomb, Inc. — enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (PMA supplement)Bausch & Lomb Corp

Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30

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Jun 18, 2025device pma421d agoCaris Life Sciences — MI Cancer Seek (PMA supplement)Caris Life Sciences, Inc.

Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: MG. Decision: OK30

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Jun 18, 2025device pma421d agoBiotronik, Inc. — Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri (PMA supplement)

Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma421d agoAlcon Laboratories, Inc. — AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (PMA supplement)Alcon Laboratories Inc

Supplement type: Normal 180 Day Track No User Fee. Product code: HQL. Advisory committee: OP. Decision: APPR

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Jun 18, 2025device pma421d agoMedtronic, Inc. — Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

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Jun 18, 2025device pma421d agoNeomend, Inc. — PROGEL Pleural Air Leak Sealant (PMA supplement)

Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: AN. Decision: OK30

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Jun 18, 2025device 510k421d agoShenzhen Wikkon Precision Technologies Co., Ltd. — Extracorporeal Shock Wave Lithotripter (U200) (510k cleared)

Product code: LNS. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Jun 18, 2025device 510k421d agoAlton (Shanghai) Medical Instruments Co., Ltd. — Ureteral Stents (AF-D series) (510k cleared)

Product code: FAD. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Jun 18, 2025device 510k421d agoSeaSpine Orthopedics Corporation — Virata Spinal Fixation System (510k cleared)

Product code: NKB. Advisory committee: Orthopedic. Type: Traditional

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Jun 18, 2025device 510k421d agoAcumed, LLC — The Acumed Wrist Fixation System (510k cleared)

Product code: HRS. Advisory committee: Orthopedic. Type: Traditional

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Jun 18, 2025device 510k421d agoHappy Health, Inc. — Happy Health Home Sleep Test (510k cleared)

Product code: MNR. Advisory committee: Anesthesiology. Type: Traditional

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Jun 18, 2025device 510k421d agoCenterPoint Systems, LLC — FlexiGo 3D Delivery Catheter (510k cleared)

Product code: DQY. Advisory committee: Cardiovascular. Type: Special

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Jun 18, 2025device 510k421d agoFisher & Paykel Healthcare Limited — F&P Nova Nasal Mask (510k cleared)

Product code: BZD. Advisory committee: Anesthesiology. Type: Traditional

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Jun 18, 2025device 510k421d agoCuriteva, Inc. — Curiteva Porous PEEK Standalone ALIF System (510k cleared)

Product code: OVD. Advisory committee: Orthopedic. Type: Traditional

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Jun 18, 2025device 510k421d agoBard Access Systems, Inc. — PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port (510k cleared)

Product code: LJT. Advisory committee: General Hospital. Type: Special

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