PMA P000009S067
- Device
- PHYLAX AV ICD SYSTEM
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S067
- Product code
- MRM
- Decision date
- 2017-02-08
- Classification
- Defibrillator, Implantable, Dual-chamber
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Approval for the ProMRI VR-T System.
Current openFDA PMA Record#
- Device
- PHYLAX AV ICD SYSTEM
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S067
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2017-02-08
- Decision code
- APPR
- Date received
- 2016-06-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the ProMRI VR-T System.