- Device
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P)
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S142
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- 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.