PMA P070008S136
- Device
- PSW 2201.U/1 and NEO 2201.U/1
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S136
- Product code
- NKE
- Decision date
- 2022-04-11
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Approval for updated programmer software versions PSW 2201.U/1 and NEO 2201.U/1.
Current openFDA PMA Record#
- Device
- PSW 2201.U/1 and NEO 2201.U/1
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S136
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-04-11
- Decision code
- APPR
- Date received
- 2022-02-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updated programmer software versions PSW 2201.U/1 and NEO 2201.U/1.