PMA P980023S110
- Device
- Drug-Eluting Permanent Defibrillator Electrodes
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S110
- Product code
- LWS
- Decision date
- 2021-12-20
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update the sampling rate for process monitoring tensile tests on select manufacturing processes.
Current openFDA PMA Record#
- Device
- Drug-Eluting Permanent Defibrillator Electrodes
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S110
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-12-20
- Decision code
- OK30
- Date received
- 2021-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the sampling rate for process monitoring tensile tests on select manufacturing processes.