PMA P950037S276

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: S276
Product code: DXY
Decision date: 2025-09-15
Classification: Cardiovascular
Generic name: implantable pacemaker Pulse-generator
Approval order statement: updates to the communication tool used in the manufacturing of IPGs and ICDs

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: S276
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2025-09-15
Decision code: OK30
Date received: 2025-08-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updates to the communication tool used in the manufacturing of IPGs and ICDs