PMA P030054S347
- Device
- Promote+, Quadra Assura, Unify, Unify Assura, and Unify Quadra
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S347
- Product code
- NIK
- Decision date
- 2018-02-01
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Relocation of supplier manufacturing of certain battery components and use of an alternate component welding machine.
Current openFDA PMA Record#
- Device
- Promote+, Quadra Assura, Unify, Unify Assura, and Unify Quadra
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S347
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-02-01
- Decision code
- OK30
- Date received
- 2018-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of supplier manufacturing of certain battery components and use of an alternate component welding machine.