PMA P000009S125
- Device
- PHYLAX AV ICD SYSTEM
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S125
- Product code
- MRM
- Decision date
- 2026-02-11
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- qualification of an alternate manufacturing site for printed circuit boards
Current openFDA PMA Record#
- Device
- PHYLAX AV ICD SYSTEM
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S125
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2026-02-11
- Decision code
- OK30
- Date received
- 2026-01-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualification of an alternate manufacturing site for printed circuit boards