PMA P950029S120

Device: Pacemakers Reply SR/DR and Esprit SR/DR
Applicant: MicroPort CRM USA, Inc.
PMA number: P950029
Supplement: S120
Product code: DXY
Decision date: 2018-03-15
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Implementation of manufacturing changes on Zener diodes used in the electronic hybrid module in the Reply and Esprit families of pacemakers.

Current openFDA PMA Record#

Device: Pacemakers Reply SR/DR and Esprit SR/DR
Applicant: MicroPort CRM USA, Inc.
PMA number: P950029
Supplement: S120
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2018-03-15
Decision code: OK30
Date received: 2018-02-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of manufacturing changes on Zener diodes used in the electronic hybrid module in the Reply and Esprit families of pacemakers.