Calendar

Week of Mar 23, 2026

Mar 27, 2026device pma143d agoMedtronic, Inc. — Medtronic CoreValve EnVeo PRO Delivery Catheter System; Medtronic Evolut PRO+ Delivery Catheter System; Medtronic Evolut (PMA supplement)Medtronic plc

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

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Mar 27, 2026device pma143d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDRS1, SED01, SEDR01, SES01, VEDR01); Adapta, Versa, Sensia IPG (SEDRL1); Ad (PMA supplement)Medtronic plc

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

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Mar 27, 2026device pma143d agoBiotronik, Inc. — Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T Enitra 6 DR-T (PMA supplement)

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

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Mar 27, 2026device pma143d 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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Mar 27, 2026device pma143d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD (PMA supplement)

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

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Mar 27, 2026device pma143d agoMedtronic, Inc. — Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (PMA supplement)Medtronic plc

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

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Mar 27, 2026device pma143d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Normal 180 Day Track. Product code: EZW. Advisory committee: GU. Decision: APPR

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Mar 27, 2026device pma143d agoABBOTT MEDICAL — Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q CDDRA800Q, CDDRA600Q CDVRA600T, C (PMA supplement)

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

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Mar 27, 2026device pma143d agoCardiva Medical, Inc. — VASCADE MVP XL VVCS Model 800-1014XL (PMA supplement)Picard Medical, Inc.

Supplement type: Panel Track. Product code: MGB. Advisory committee: CV. Decision: APPR

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Mar 27, 2026device pma143d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (PMA supplement)

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

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Mar 27, 2026device pma143d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Normal 180 Day Track. Product code: QON. Advisory committee: GU. Decision: APPR

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Mar 27, 2026device pma143d agoMedtronic, Inc. — Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG (PMA supplement)Medtronic plc

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

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Mar 27, 2026device pma143d agoABBOTT MEDICAL — Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T); Gallant ( (PMA supplement)

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

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Mar 28, 2026device 510k142d agoSanhe Meditech Co., Ltd. — CO2 Laser System (510k cleared)

Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

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Mar 28, 2026device 510k142d agoAnumana, Inc. — ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) (510k cleared)

Product code: SAT. Advisory committee: Cardiovascular. Type: Traditional

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Mar 28, 2026grant142d agoRUTGERS THE STATE UNIV OF NJ NEWARK — Neural and Behavioral Correlates of Similarity, Trustworthiness, and Stress i...

DA grant. $81,580. PI: William John Mitchell

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Week of Mar 30, 2026

Mar 30, 2026approval140d agoLAMOTRIGINE — FDA approvalTorrent Pharma Inc

Sponsor: TARO PHARM INDS. Form: TABLET. Route: ORAL

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Mar 30, 2026approval

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