PMA P950037S287
- Device
- Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T Enitra 6 DR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S287
- Product code
- DXY
- Decision date
- 2026-03-27
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- relocating a feedthrough assembly manufacturing site
Current openFDA PMA Record#
- Device
- Pulse Generator, Permanent Implantable Edora 8 DR-T Evity 8 DR-T Enitra 8 DR-T Enticos 8 DR-T Evity 6 DR-T Enitra 6 DR-T
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S287
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2026-03-27
- Decision code
- OK30
- Date received
- 2026-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- relocating a feedthrough assembly manufacturing site