- Device
- Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S216
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2020-11-17
- Decision code
- OK30
- Date received
- 2020-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the insulating foil geometry and add adhesive to improve the manufacturing process.