PMA P050023S203
- Device
- Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S203
- Product code
- MRM
- Decision date
- 2025-10-16
- Classification
- Cardiovascular
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Approval order statement
- introducing an alternative supplier for a set screw component
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; Intica 7 VR-T 404634; I
- Applicant
- Biotronik, Inc.
- PMA number
- P050023
- Supplement
- S203
- Product code
- MRM
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Decision date
- 2025-10-16
- Decision code
- OK30
- Date received
- 2025-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introducing an alternative supplier for a set screw component