PMA P950037S291
- Device
- PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky DR-T, Amvia Sky SR-T, Amvia Edg
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S291
- Product code
- DXY
- Decision date
- 2026-09-17
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- approval for updated programmer software PSW 2601.U and NEO 2601.U
Current openFDA PMA Record#
- Device
- PSW 2601.U, NEO 2601.U, Amvia Sky HF-T QP, Amvia Sky HF-T, Amvia Edge HF-T QP, Amvia Sky DR-T, Amvia Sky SR-T, Amvia Edg
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S291
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-09-17
- Decision code
- APPR
- Date received
- 2026-04-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for updated programmer software PSW 2601.U and NEO 2601.U