PMA P070008S128

Device: Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S128
Product code: NKE
Decision date: 2021-08-19
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: Implement new automated equipment for their pickling process associated with various components used in manufacture of IPGs, ICDs, and leads.

Current openFDA PMA Record#

Device: Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T
Applicant: Biotronik, Inc.
PMA number: P070008
Supplement: S128
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2021-08-19
Decision code: OK30
Date received: 2021-07-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implement new automated equipment for their pickling process associated with various components used in manufacture of IPGs, ICDs, and leads.