PMA P980023S115
- Device
- Permanent Defibrillator Electrodes
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S115
- Product code
- LWS
- Decision date
- 2022-10-20
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update process monitoring sampling and remove redundant testing and inspection processes.
Current openFDA PMA Record#
- Device
- Permanent Defibrillator Electrodes
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S115
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-10-20
- Decision code
- OK30
- Date received
- 2022-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update process monitoring sampling and remove redundant testing and inspection processes.