Quadripolar Pacing
FDA premarket approval P030054/S372 · decided 2019-12-20
Approval details
- PMA number
- P030054
- Supplement
- S372
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Quadripolar Pacing
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-10-09
- Decision date
- 2019-12-20
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for updates to the users manual to include a new section that reflects long-term safety and effectiveness data from the Quadripolar Pacing Post Approval Study.
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