Calendar

pharmadog

Week of Jan 19, 2026

Jan 23, 2026device 510k203d agoElidah, Inc. — Elitone for Men (510k cleared)

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

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Jan 23, 2026device pma203d agoMedtronic Vascular, Inc. — Protégé RX Carotid Stent System (PMA supplement)

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

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Jan 23, 2026device pma203d agoMed-El Corp. — MED-EL Cochlear Implant (PMA supplement)

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

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Jan 23, 2026device pma203d agoQiagen — QuantiFERON®-TB Gold Test and QuantiFERON®-TB Gold Plus Test (PMA supplement)QIAGEN N.V.

Supplement type: 30-Day Notice. Product code: NCD. Advisory committee: MI. Decision: OK30

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Jan 23, 2026device pma203d 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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Jan 23, 2026device pma203d 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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Jan 23, 2026device pma203d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Eve (PMA supplement)

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

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Jan 23, 2026device pma203d agoMedtronic, Inc. — Percepta Bipolar CRT-P; Perceota Quadrioolar 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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Jan 23, 2026device pma203d agoMedtronic, Inc. — Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRTP; Serena Quadripolar CRT-P; Solar (PMA supplement)Medtronic plc

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

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Jan 23, 2026device pma203d agoMedtronic Minimed — MiniMed Go app; Simplera sensor (PMA supplement)

Supplement type: Real-Time Process. Product code: MDS. Advisory committee: CH. Decision: APPR

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Jan 23, 2026device pma203d agoAdvanced Bionics — HiResolution Bionic Ear System (PMA supplement)

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

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Jan 23, 2026device pma203d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (PMA supplement)

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

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Jan 23, 2026device pma203d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advis (PMA supplement)Medtronic plc

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

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Jan 23, 2026device recall203d agoI.T.S. GmbH device recall (Cls II)

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-100, 31757-120, 31757-45, 31757-80, 31757-85, 31757-90. — Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). — Status: Ongoing

Week of Jan 19, 2026