PMA P050023S211
- Device
- PSW 2601.U, NEO 2601.U, Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, R
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S211
- Product code
- MRM
- Decision date
- 2026-09-17
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- approval for updated programmer software PSW 2601.U and NEO 2601.U
Current openFDA PMA Record#
- Device
- PSW 2601.U, NEO 2601.U, Acticor Sky HF-T, Rivacor Sky HF-T, Rivacor Rise HF-T, Rivacor Aura HF-T, Acticor Sky HF-T QP, R
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S211
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2026-09-17
- Decision code
- APPR
- Date received
- 2026-04-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for updated programmer software PSW 2601.U and NEO 2601.U