PMA P050023S208
- Device
- Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S208
- Product code
- MRM
- Decision date
- 2026-03-05
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- to introduce an additional supplier of battery feedthroughs
Current openFDA PMA Record#
- Device
- Acticor 7 VR-T (429526); Rivacor 7 VR-T (429536); Rivacor 5 VR-T (429565); Rivacor 3 VR-T (429574); Acticor 7 VR-T DX (4
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S208
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2026-03-05
- Decision code
- OK30
- Date received
- 2026-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to introduce an additional supplier of battery feedthroughs