PMA P000009S127
- Device
- Renamic Neo
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S127
- Product code
- MRM
- Decision date
- 2026-04-24
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- approval for display and programming head updates to Renamic Neo programmer
Current openFDA PMA Record#
- Device
- Renamic Neo
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S127
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2026-04-24
- Decision code
- APPR
- Date received
- 2026-01-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for display and programming head updates to Renamic Neo programmer