Quadra Allure, Quadra Allure MP
FDA premarket approval P030035/S203 · decided 2024-09-26
Approval details
- PMA number
- P030035
- Supplement
- S203
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Quadra Allure, Quadra Allure MP
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-06-28
- Decision date
- 2024-09-26
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- approval for expanding MR Conditional labeling for Quadra Allure and Allure MP Cardiac Resynchronization Therapy Pacemaker (CRT-P) systems with Tendril STS, UltiPace, Quartet, and IsoFlex pacing leads.
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