- Device
- Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S141
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-11-16
- Decision code
- OK30
- Date received
- 2022-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate suppliers for several injection molded silicone parts used in Sentus QP left ventricular pacing leads.