PMA P000009S132
- Device
- Acticor Sky DR-T 481987; Rivacor Sky DR-T 481982; Rivacor Rise DR-T 482018; Rivacor Aura DR-T 482014
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S132
- Product code
- MRM
- Decision date
- 2026-10-09
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- battery separator pocket material change and new additive to battery electrolyte.
Current openFDA PMA Record#
- Device
- Acticor Sky DR-T 481987; Rivacor Sky DR-T 481982; Rivacor Rise DR-T 482018; Rivacor Aura DR-T 482014
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S132
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2026-10-09
- Decision code
- APPR
- Date received
- 2026-07-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- battery separator pocket material change and new additive to battery electrolyte.