- Device
- Implantable Cardioverter Defibrillator (Non-CRT)
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S096
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-05-11
- Decision code
- APPR
- Date received
- 2019-11-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for optimization changes of the MnO2 thermal treatment process and automation of ICD battery cathode manufacturing.