PMA P950022S142
- Device
- Optisure™
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S142
- Product code
- LWS
- Decision date
- 2021-12-01
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for a labeling update to include the findings of the Optisure Post-Approval Study.
Current openFDA PMA Record#
- Device
- Optisure™
- Applicant
- ABBOTT MEDICAL
- PMA number
- P950022
- Supplement
- S142
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-12-01
- Decision code
- APPR
- Date received
- 2021-10-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for a labeling update to include the findings of the Optisure Post-Approval Study.