PMA P910023S446
- Device
- Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR and Entrant DR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S446
- Product code
- LWS
- Decision date
- 2022-07-14
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Second-tier supplier's manufacturing site transfer.
Current openFDA PMA Record#
- Device
- Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR and Entrant DR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S446
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-07-14
- Decision code
- OK30
- Date received
- 2022-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Second-tier supplier's manufacturing site transfer.