PMA P050023S201

Device: Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Ilivia 7 DF4 VR-T 40462
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S201
Product code: MRM
Decision date: 2025-09-15
Classification: Cardiovascular
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: updates to the communication tool used in the manufacturing of IPGs and ICDs

Current openFDA PMA Record#

Device: Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Ilivia 7 DF4 VR-T 40462
Applicant: Biotronik, Inc.
PMA number: P050023
Supplement: S201
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
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