PMA P030054S356
- Device
- Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S356
- Product code
- NIK
- Decision date
- 2019-01-03
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- 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
- P030054
- Supplement
- S356
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- 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.