PMA P950029S119
- Device
- Reply SR, Reply DR, Esprit SR, Esprit DR
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P950029
- Supplement
- S119
- Product code
- DXY
- Decision date
- 2018-01-29
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Add a new supplier for silicone cap components for use in the device header.
Current openFDA PMA Record#
- Device
- Reply SR, Reply DR, Esprit SR, Esprit DR
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P950029
- Supplement
- S119
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2018-01-29
- Decision code
- OK30
- Date received
- 2018-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new supplier for silicone cap components for use in the device header.