PMA P000009
- 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
- S100
- Product code
- MRM
- Decision date
- 2026-06-24
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- the introduction of an alternate anchor welding machine
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
- S131
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2026-06-24
- Decision code
- OK30
- Date received
- 2026-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the introduction of an alternate anchor welding machine