- Device
- Enticos 4 DR, Enticos 4 D, Enticos 4 SR, Enticos 4 S, Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S219
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2021-04-01
- Decision code
- OK30
- Date received
- 2021-03-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce in-house production of the outer wiring bands for headers for Edora, Evity, Entira, and Enticos devices.