PMA P030054S338
- Device
- Unify / Unify Quadra / Unify Assura / Quadra Assura / Quadra Assura MP
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S338
- Product code
- NIK
- Decision date
- 2017-10-18
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Addition of an alternate supplier of high voltage hybrid components for use in ICD and CRT-D devices.
Current openFDA PMA Record#
- Device
- Unify / Unify Quadra / Unify Assura / Quadra Assura / Quadra Assura MP
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S338
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-10-18
- Decision code
- OK30
- Date received
- 2017-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier of high voltage hybrid components for use in ICD and CRT-D devices.