PMA P050023S097
- Device
- TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S097
- Product code
- MRM
- Decision date
- 2016-05-27
- Classification
- Defibrillator, Implantable, Dual-chamber
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- Approval for programmer software PSW 1506.U/1.
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
- S097
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2016-05-27
- Decision code
- APPR
- Date received
- 2016-03-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for programmer software PSW 1506.U/1.