- Device
- Edora 8 HF-T QP (407137); Edora 8 HF-T (407138); Evity 8 HF-T QP (407139); Evity 8 HF-T (407140); Enitra 8 HF-T QP (4071
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S169
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2025-09-11
- Decision code
- OK30
- Date received
- 2025-08-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to visual inspection acceptance criteria for seal coupler outer sealing lips of 4-pole modules