Calendar

pharmadog

Week of Apr 6, 2026

Apr 9, 2026device pma91d agoSynergy Spine Solutions, Inc. — Synergy Disc (PMA supplement)

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

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Apr 9, 2026device pma91d agoAsahi Kasei Medical Co., Ltd. — Plasmaflo OP-05 W(A) (PMA supplement)

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

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Apr 9, 2026device pma91d agoW. L. Gore & Associates, Inc. — GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) (PMA supplement)

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

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Apr 9, 2026device pma91d agoMedtronic, Inc. — Avalus Bioprosthesis (PMA supplement)Medtronic plc

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

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Apr 9, 2026device pma91d agoEv3 Neurovascular — Apollo Onyx Delivery Micro Catheter (PMA supplement)

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

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Apr 9, 2026device pma91d agoAdvanced Bionics — HiResolution Bionic Ear System Ultra and Ultra 3D Thin PCB (PMA supplement)

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

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Apr 9, 2026device pma91d agoNovocure, GmbH — Optune HFE Transducer Array Soft Part Components (PMA supplement)NovoCure Ltd

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

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Apr 9, 2026device pma91d agoCooperVision, Inc. — Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio (PMA supplement)

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

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Apr 9, 2026device pma91d 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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Apr 9, 2026device pma91d agoMedtronic, Inc. — Melody Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

Supplement type: 135 Review Track For 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: APPR

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Apr 9, 2026device pma91d agoEdwards Lifesciences, LLC — SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (PMA supplement)Edwards Lifesciences Corp

Supplement type: Real-Time Process. Product code: NPT. Advisory committee: CV. Decision: APPR

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Apr 9, 2026device pma91d agoEdwards Lifesciences, LLC — Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (PMA supplement)Edwards Lifesciences Corp

Supplement type: Real-Time Process. Product code: NPV. Advisory committee: CV. Decision: APPR

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Apr 9, 2026device pma91d agoBoston Scientific Corp — Rotablator; ROTAPRO Rotational Atherectomy Systems (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Apr 9, 2026device pma91d agoABBOTT MEDICAL — FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) (PMA supplement)

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

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Apr 10, 2026device pma90d agoBoston Scientific — Lead Port Plug Model 6996 (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoZoll Circulation, Inc. — TherOx Downstream System (PMA supplement)

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

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Apr 10, 2026device pma90d agoAutoGenomics, Inc. — AvertD and AvertD Buccal Sample Collection Kit (PMA supplement)NEOGENOMICS INC

Supplement type: Real-Time Process. Product code: QZH. Advisory committee: TX. Decision: APPR

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Apr 10, 2026device pma90d agoBoston Scientific Corp — Suture Sleeve Model 4603, 6402 , ACUITY X4 Flushing tool/Wire guide Model 4604, Lead Cap Model 6742, Torque Wrench, Mode (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: NIK. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoBoston Scientific — Wrench Kit Model 6501 (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoBoston Scientific — Vein Pick Model 6541 (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoBoston Scientific Corporation — TheraSphere (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Apr 10, 2026device pma90d agoDePuy Orthopaedics, Inc. — Ceramax Ceramic Hip System (PMA supplement)

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

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Apr 10, 2026device pma90d agoMicroTransponder, Inc. — Vivistim® System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QPY. Advisory committee: PM. Decision: OK30

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Apr 10, 2026device pma90d agoBoston Scientific — Lead Stylets, Straight, X-Soft Models 5003, 5004, 5005 Lead Stylets, Long Tapered, Soft Models 5012, 5013, 5014 (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWP. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoBoston Scientific — Straight Lead Stylets Limber Models 6033, 6034; Straight Lead Stylets Firm Models 6036, 6037; J Shaped Lead Stylets Limb (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: NVN. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoMedtronic — HEARTWARE VENTRICULAR ASSIST SYSTEM (PMA supplement)Medtronic plc

Supplement type: Normal 180 Day Track. Product code: DSQ. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoBoston Scientific — ACUITY X4 Connector Tool Model 4625 AICD Lead Stylets Firm Model 6971 AICD Lead Stylets Soft Model 6972 Suture S (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

Supplement type: Special (Immediate Track). Product code: NPW. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoBoston Scientific — Fixation Tool Model 6616 (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: NVN. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoImpulse Dynamics (Usa), Inc. — GUARDIO/VESTA Charger (PMA supplement)

Supplement type: Real-Time Process. Product code: QFV. Advisory committee: CV. Decision: APPR

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Apr 10, 2026device pma90d agoOrganox Limited — OrganOx metra® System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: QQK. Advisory committee: GU. Decision: APPR

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Apr 10, 2026device pma90d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

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

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Week of Apr 20, 2026

Apr 23, 2026earnings77d agoACME UNITED CORP earningsACME UNITED CORP

Anticipated earnings call for ACME UNITED CORP ($ACU).

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Apr 23, 2026earnings

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