Cardiac Resynchronization Therapy -Defibrillator (CRT-D)
FDA premarket approval P010031/S897 · decided 2025-09-09
Approval details
- PMA number
- P010031
- Supplement
- S897
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Cardiac Resynchronization Therapy -Defibrillator (CRT-D)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- 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
- NIK
- 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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