Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)
FDA premarket approval P960013/S099 · decided 2019-01-03
Approval details
- PMA number
- P960013
- Supplement
- S099
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-06-28
- Decision date
- 2019-01-03
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for new models of cardiac resynchronization therapy pacemakers (CRT-P) devices, Quadra Allure PM3542 and Quadra Allure MP PM3562
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