Cardiac Resynchronization Therapy Defibrillator (CRT-D)
FDA premarket approval P950022/S109 · decided 2017-12-19
Approval details
- PMA number
- P950022
- Supplement
- S109
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cardiac Resynchronization Therapy Defibrillator (CRT-D)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-07-03
- Decision date
- 2017-12-19
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for MR Conditional labeling for Fortify Assura ICDs, Quadra Assura and Quadra Assura MP CRT-Ds, and Durata, Optisure, Tendril MRI and Quartet lead systems.
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