Implantable Cardioverter Defibrillator (ICD)
FDA premarket approval P980016/S931 · decided 2025-09-09
Approval details
- PMA number
- P980016
- Supplement
- S931
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Implantable Cardioverter Defibrillator (ICD)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2025-07-11
- Decision date
- 2025-09-09
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- approval for a labeling update to include the findings of the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS).
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