- Device
- Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S383
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-08-06
- Decision code
- OK30
- Date received
- 2020-07-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate supplier for the metal case and lid used to manufacture HV Capacitor.