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
Biotronik, Inc. · DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER · Cardiovascular
Open FDA's page for this record- PMA number
- P050023
- Supplement number
- S211
- Applicant
- Biotronik, Inc.
- Street 1
- 6024 Jean Rd.
- City
- Lake Oswego
- State
- OR
- Zip
- 97035
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Trade name
- 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
- Product code
- MRM
- Advisory committee
- CV
- Advisory committee description
- Cardiovascular
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Expedited review flag
- N
- Date received
- 2026-04-15
- Decision date
- 2026-09-17
- Decision code
- APPR
- Ao statement
- approval for updated programmer software PSW 2601.U and NEO 2601.U
- Harmonized identifiers (openFDA)
- Device name
- Defibrillator, Implantable, Dual-Chamber
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 1000165971, 3002806603, 9610139, 3008159616, 3005941719, 1028232
- FEI number
- 1000165971, 3002806603, 3008159616, 1028232, 3002806500, 3002807111