PMA P980049S127

Device: Implantable Cardioverter Defibrillator ICDs
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S127
Product code: MRM
Decision date: 2018-01-25
Classification: Defibrillator, Implantable, Dual-chamber
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Approval order statement: Replace the solder mask material, to allow for rework of RF modules on hybrids, and to incorporate use of alternate thermosealing equipment during the packaging process.

Current openFDA PMA Record#

Device: Implantable Cardioverter Defibrillator ICDs
Applicant: MicroPort CRM USA, Inc.
PMA number: P980049
Supplement: S127
Product code: MRM
Generic name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
Decision date: 2018-01-25
Decision code: OK30
Date received: 2018-01-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replace the solder mask material, to allow for rework of RF modules on hybrids, and to incorporate use of alternate thermosealing equipment during the packaging process.