PMA P030054S352
- Device
- Unify, Unify Quadra, Unify Assura, Quadra Assura and Quadra Assura MP
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S352
- Product code
- NIK
- Decision date
- 2018-04-03
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Use of a plastic ring frame as an alternative to a ceramic frame in hybrids.
Current openFDA PMA Record#
- Device
- Unify, Unify Quadra, Unify Assura, Quadra Assura and Quadra Assura MP
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S352
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-04-03
- Decision code
- OK30
- Date received
- 2018-03-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a plastic ring frame as an alternative to a ceramic frame in hybrids.