PMA P050023S160

Device: Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T (
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S160
Product code: MRM
Decision date: 2021-08-19
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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: Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T (
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S160
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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.