PMA P980023S116
- Device
- Implantable Cardioverter Defibrillator (Non-CRT)
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S116
- Product code
- LWS
- Decision date
- 2022-12-07
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Introduce an automatic optical inspection of the blister packaging for IPGs and ICDs.
Current openFDA PMA Record#
- Device
- Implantable Cardioverter Defibrillator (Non-CRT)
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S116
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-12-07
- Decision code
- OK30
- Date received
- 2022-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce an automatic optical inspection of the blister packaging for IPGs and ICDs.