PMA P910023S431
- Device
- Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S431
- Product code
- LWS
- Decision date
- 2020-08-06
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add an alternate supplier for the metal case and lid used to manufacture HV Capacitor.
Current openFDA PMA Record#
- Device
- Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S431
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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.