PSW 2601.U, NEO 2601.U
Biotronik, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) · Cardiovascular
Open FDA's page for this record- PMA number
- P070008
- Supplement number
- S179
- Applicant
- Biotronik, Inc.
- Street 1
- 6024 Jean Rd.
- City
- Lake Oswego
- State
- OR
- Zip
- 97035
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Trade name
- PSW 2601.U, NEO 2601.U
- Product code
- NKE
- 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
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3033257494, 9610139, 3009380063, 1028232, 2182208, 2017865, 3005334138, 3008483389, 3012552532, 3008494315, 9616693, 2124215, 2135338, 2649622, 3015453963, 3006705815, 3003120897, 3013596024, 2032521, 3013500228, 9614453, 3013288201, 1220452, 3018094310, 2133641
- FEI number
- 3033257494, 3009380063, 1028232, 2182208, 2017865, 3005334138, 3008483389, 3012552532, 3005700659, 2124215, 3002806500, 2649622, 3015453963, 3006705815, 3003120897, 3013596024, 3000203466, 3002618605, 3013500228, 3002807576, 3003574398, 3013288201, 1220452, 3018094310, 3008377825