- Device
- Defibrillator, Automatic Implantable Cardioverter with Cardiac Resynchronization (CRT-D), Implantable Cardioverter Defib
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S139
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2020-05-11
- Decision code
- APPR
- Date received
- 2019-11-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for optimization changes of the MnO2 thermal treatment process and automation of ICD battery cathode manufacturing.