PMA P950037S285
- Device
- Renamic Neo
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S285
- Product code
- DXY
- Decision date
- 2026-04-24
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- 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
- P950037
- Supplement
- S285
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- 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