PMA P000009S086
- Device
- Phylax AV ICD System
- Applicant
- Biotronik, Inc.
- Product code
- MRM
- Decision date
- 2021-03-08
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Approval for the Renamic Neo Programmer and updated software platforms.
Current openFDA PMA Record#
- Device
- Phylax AV ICD System
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S086
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2021-03-08
- Decision code
- APPR
- Date received
- 2020-06-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Renamic Neo Programmer and updated software platforms.