PMA P030054S331
- Device
- Promote, Unify Quadra, Assura, Quadra Assura
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S331
- Product code
- NIK
- Decision date
- 2017-07-26
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Reduction in time for the burn-in environmental screen used during the processing of high voltage RF Module assemblies.
Current openFDA PMA Record#
- Device
- Promote, Unify Quadra, Assura, Quadra Assura
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S331
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-07-26
- Decision code
- OK30
- Date received
- 2017-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in time for the burn-in environmental screen used during the processing of high voltage RF Module assemblies.