PMA P030054S351
- Device
- Unify CD3231-40, CD3231-40Q; Unify Quadra CD3249-40, CD3249-40Q; Unify Assura CD3257-40, CD3257-40Q, CD3357-40, CD3357-4
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S351
- Product code
- NIK
- Decision date
- 2018-04-04
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Add an alternate supplier for the metal ring frame used in the hybrid.
Current openFDA PMA Record#
- Device
- Unify CD3231-40, CD3231-40Q; Unify Quadra CD3249-40, CD3249-40Q; Unify Assura CD3257-40, CD3257-40Q, CD3357-40, CD3357-4
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S351
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-04-04
- Decision code
- OK30
- Date received
- 2018-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier for the metal ring frame used in the hybrid.