PMA P030054S358
- Device
- Promote+; Unify; Unify Quadra; Unify Assura; Quadra Assura; Quadra Assura (MR Conditional); Quadra Assura MP; Quadra Ass
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S358
- Product code
- NIK
- Decision date
- 2018-08-14
- 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 frequency of bioburden testing at the Penang, Malaysia manufacturing site.
Current openFDA PMA Record#
- Device
- Promote+; Unify; Unify Quadra; Unify Assura; Quadra Assura; Quadra Assura (MR Conditional); Quadra Assura MP; Quadra Ass
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S358
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-08-14
- Decision code
- OK30
- Date received
- 2018-07-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction in frequency of bioburden testing at the Penang, Malaysia manufacturing site.