PMA P070008S120
- Device
- Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S120
- Product code
- NKE
- Decision date
- 2020-12-01
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Replace 100% Bake and Out Gas testing of electronic module components with lot sampling.
Current openFDA PMA Record#
- Device
- Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S120
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2020-12-01
- Decision code
- OK30
- Date received
- 2020-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace 100% Bake and Out Gas testing of electronic module components with lot sampling.