PMA P070008S143
- Device
- Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S143
- Product code
- NKE
- Decision date
- 2023-01-12
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Approval for programmer software versions PSW 2202.U and NEO 2202.U.
Current openFDA PMA Record#
- Device
- Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S143
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2023-01-12
- Decision code
- APPR
- Date received
- 2022-11-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for programmer software versions PSW 2202.U and NEO 2202.U.