PMA P950037S286
- Device
- Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S286
- Product code
- DXY
- Decision date
- 2026-03-05
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- to introduce an additional supplier of battery feedthroughs
Current openFDA PMA Record#
- Device
- Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S286
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-03-05
- Decision code
- OK30
- Date received
- 2026-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to introduce an additional supplier of battery feedthroughs