PMA P950037S213
- Device
- Renamic Neo Programmer
- Applicant
- Biotronik, Inc.
- Product code
- OSR
- Decision date
- 2021-03-08
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- Approval for the Renamic Neo Programmer and updated software platforms.
Current openFDA PMA Record#
- Device
- Renamic Neo Programmer
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S213
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2021-03-08
- Decision code
- APPR
- Date received
- 2020-06-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Renamic Neo Programmer and updated software platforms.