PMA P950037S252
- Device
- PSW 2303.U, NEO 2303.U
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S252
- Product code
- OSR
- Decision date
- 2023-12-13
- Classification
- Cardiovascular
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- approval for the PSW 2303.U and NEO 2303.U programmer software
Current openFDA PMA Record#
- Device
- PSW 2303.U, NEO 2303.U
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S252
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2023-12-13
- Decision code
- APPR
- Date received
- 2023-09-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the PSW 2303.U and NEO 2303.U programmer software