PMA P000009S129
- Device
- Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S129
- Product code
- MRM
- Decision date
- 2026-05-07
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- laser machine manufacturing parameter adjustments
Current openFDA PMA Record#
- Device
- Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aura DR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P000009
- Supplement
- S129
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2026-05-07
- Decision code
- OK30
- Date received
- 2026-04-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- laser machine manufacturing parameter adjustments