PMA P050023S148
- Device
- Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead
- Applicant
- Biotronik, Inc.
- Product code
- MRM
- Decision date
- 2021-03-08
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Approval for the Renamic Neo Programmer and updated software platforms.
Current openFDA PMA Record#
- Device
- Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S148
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- 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.