- Device
- Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S140
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-10-20
- Decision code
- OK30
- Date received
- 2022-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update process monitoring sampling and remove redundant testing and inspection processes.