PMA P000009S089
- Device
- Phylax AV ICD System
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S089
- Product code
- MRM
- Decision date
- 2020-12-18
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Implement automated cleaning equipment during an intermediate cleaning step.
Current openFDA PMA Record#
- Device
- Phylax AV ICD System
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S089
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2020-12-18
- Decision code
- OK30
- Date received
- 2020-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement automated cleaning equipment during an intermediate cleaning step.