- Device
- Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S168
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2022-12-07
- Decision code
- OK30
- Date received
- 2022-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce an automatic optical inspection of the blister packaging for IPGs and ICDs.