PMA P980023S118
- Device
- Protego EP PASSION
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S118
- Product code
- LWS
- Decision date
- 2023-01-16
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for updated labeling to include a clinical summary for the Protego DF4 Post Approval Registry.
Current openFDA PMA Record#
- Device
- Protego EP PASSION
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S118
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2023-01-16
- Decision code
- APPR
- Date received
- 2022-11-30
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated labeling to include a clinical summary for the Protego DF4 Post Approval Registry.