- 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
- P950037
- Supplement
- S227
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- 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.