PMA P950029S117

Device: REPLY & ESPRIT SR & DR Pacemakers
Applicant: MicroPort CRM USA, Inc.
PMA number: P950029
Supplement: S117
Product code: DXY
Decision date: 2018-01-29
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
Approval order statement: Modify the gluing process of the silicone caps, X-ray tag, and header cavities and to move the assembly sequence of the bal seal springs for the header.

Current openFDA PMA Record#

Device: REPLY & ESPRIT SR & DR Pacemakers
Applicant: MicroPort CRM USA, Inc.
PMA number: P950029
Supplement: S117
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 2018-01-29
Decision code: OK30
Date received: 2018-01-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modify the gluing process of the silicone caps, X-ray tag, and header cavities and to move the assembly sequence of the bal seal springs for the header.