PMA P950037S277

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: S277
Product code: NVZ
Decision date: 2025-10-01
Classification: Cardiovascular
Generic name: Pulse generator, permanent, implantable
Approval order statement: introducing a temporary, additional incoming visual inspection of outer packaging

Current openFDA PMA Record#

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: S277
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2025-10-01
Decision code: APPR
Date received: 2025-09-05
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: introducing a temporary, additional incoming visual inspection of outer packaging