Quadra Assura, Unify, Unify Assura and Unify Quadra Family of CRT-D
FDA premarket approval P030054/S411 · decided 2023-09-20
Approval details
- PMA number
- P030054
- Supplement
- S411
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Quadra Assura, Unify, Unify Assura and Unify Quadra Family of CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-08-23
- Decision date
- 2023-09-20
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Replace the graphite powder used during battery manufacturing with two alternatives.
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