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
Biotronik, Inc. · implantable pacemaker Pulse-generator · Cardiovascular
Open FDA's page for this record- PMA number
- P950037
- Supplement number
- S291
- Applicant
- Biotronik, Inc.
- Street 1
- 6024 Jean Rd.
- City
- Lake Oswego
- State
- OR
- Zip
- 97035
- Generic name
- implantable pacemaker Pulse-generator
- Trade name
- 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
- Product code
- DXY
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Expedited review flag
- N
- Date received
- 2026-04-15
- Decision date
- 2026-09-17
- Decision code
- APPR
- Ao statement
- approval for updated programmer software PSW 2601.U and NEO 2601.U
- Harmonized identifiers (openFDA)
- Device name
- Implantable Pacemaker Pulse-Generator
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.3610
- Device class
- 3
- Registration number
- 3033257494, 1000165971, 9610139, 3004209178, 3009380063, 1028232, 2182208, 2017865, 3005334138, 3008483389, 3012552532, 2024024, 3008494315, 3004593495, 2124215, 2135338, 2649622, 3002806603, 3006705815, 3003120897, 2648729, 2032521, 9614453, 3008159616, 3013288201, 3018094310, 2133641, 3008973940
- FEI number
- 3033257494, 1000165971, 3009380063, 1028232, 2182208, 2017865, 3005334138, 3008483389, 3012552532, 2024024, 3005700659, 3004593495, 2124215, 3004369318, 3002806500, 2649622, 3008973940, 3002806603, 3006705815, 3003120897, 3000203466, 2648729, 3002807576, 3003574398, 3008159616, 3013288201, 3018094310, 3008377825