PMA P030054S314
- Device
- QUARTET 1457Q LV LEAD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S314
- Product code
- NIK
- Decision date
- 2017-03-15
- 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 Quartet 1457Q left ventricular lead model.
Current openFDA PMA Record#
- Device
- QUARTET 1457Q LV LEAD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S314
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-03-15
- Decision code
- APPR
- Date received
- 2016-11-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Quartet 1457Q left ventricular lead model.