PMA P960013S099
- Device
- Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S099
- Product code
- NVN
- Decision date
- 2019-01-03
- Classification
- Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- Approval for new models of cardiac resynchronization therapy pacemakers (CRT-P) devices, Quadra Allure PM3542 and Quadra Allure MP PM3562
Current openFDA PMA Record#
- Device
- Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P960013
- Supplement
- S099
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2019-01-03
- Decision code
- APPR
- Date received
- 2018-06-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for new models of cardiac resynchronization therapy pacemakers (CRT-P) devices, Quadra Allure PM3542 and Quadra Allure MP PM3562