PMA P980049S130

Device: Paradym RF VR 9250, Paradym RF DR 9550, Platinium VR 1210, Platinium VR 1240, Platinium DR 1510, Platinium DR 1540
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S130
Product code: MRM
Decision date: 2018-04-25
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: Minor sterilization cycle and sterilization equipment changes.

Current openFDA PMA Record#

Device: Paradym RF VR 9250, Paradym RF DR 9550, Platinium VR 1210, Platinium VR 1240, Platinium DR 1510, Platinium DR 1540
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S130
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2018-04-25
Decision code: OK30
Date received: 2018-03-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Minor sterilization cycle and sterilization equipment changes.