PMA P980049S132

Device: ICDs (Implantable Cardioverter Defibrillator) Platinium VR/DR
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S132
Product code: MRM
Decision date: 2018-12-06
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: Add equipment used for solder past printing during electronic assembly and add a rework process used for component replacement.

Current openFDA PMA Record#

Device: ICDs (Implantable Cardioverter Defibrillator) Platinium VR/DR
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S132
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2018-12-06
Decision code: OK30
Date received: 2018-11-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add equipment used for solder past printing during electronic assembly and add a rework process used for component replacement.