PMA P980049S131

Device: Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL 102) Intensia VR ICD, Intensia DR, Platinium VR, Platinium DR
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S131
Product code: MRM
Decision date: 2018-05-14
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: Addition of an alternate automated visual inspection for incoming inspection of die after dicing.

Current openFDA PMA Record#

Device: Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL 102) Intensia VR ICD, Intensia DR, Platinium VR, Platinium DR
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S131
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2018-05-14
Decision code: OK30
Date received: 2018-04-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of an alternate automated visual inspection for incoming inspection of die after dicing.