PMA P980023S109
- Device
- PHYLAX AV ICD SYSTEM
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S109
- Product code
- LWS
- Decision date
- 2021-10-29
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Optimize the sterilization process parameters for P01 and P02 and propose a load change for P01.
Current openFDA PMA Record#
- Device
- PHYLAX AV ICD SYSTEM
- Applicant
- Biotronik, Inc.
- PMA number
- P980023
- Supplement
- S109
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-10-29
- Decision code
- OK30
- Date received
- 2021-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Optimize the sterilization process parameters for P01 and P02 and propose a load change for P01.