PMA P950037S282
- Device
- Amvia-Solvia Pulse Generators Scan Duration Extension
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S282
- Product code
- DXY
- Decision date
- 2026-03-30
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for extending the MRI scan duration to at least 60 minutes and additional MRI follow up and labeling updates.
Current openFDA PMA Record#
- Device
- Amvia-Solvia Pulse Generators Scan Duration Extension
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S282
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-03-30
- Decision code
- APPR
- Date received
- 2025-12-30
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for extending the MRI scan duration to at least 60 minutes and additional MRI follow up and labeling updates.