PMA P000009

Device: Ilivia Neo 7 DRT, Intica Neo 7 DRT, Intica Neo 5 DRT, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aur
Applicant: Biotronik, Inc.
PMA number: P000009
Supplement: S100
Product code: MRM
Decision date: 2026-10-22
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: updating visual and dimensional incoming inspection testing for certain components and raw materials used in IPG, ICD, and lead manufacturing

Current openFDA PMA Record#

Device: Ilivia Neo 7 DRT, Intica Neo 7 DRT, Intica Neo 5 DRT, Acticor Sky DR-T, Rivacor Sky DR-T, Rivacor Rise DR-T, Rivacor Aur
Applicant: Biotronik, Inc.
PMA number: P000009
Supplement: S135
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2026-10-22
Decision code: OK30
Date received: 2026-09-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: updating visual and dimensional incoming inspection testing for certain components and raw materials used in IPG, ICD, and lead manufacturing