PMA P950029S118
- Device
- Reply SR / Esprit SR / Reply DR / Esprit DR
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P950029
- Supplement
- S118
- Product code
- DXY
- Decision date
- 2018-03-11
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for software updates to the embedded device and remote monitoring system.
Current openFDA PMA Record#
- Device
- Reply SR / Esprit SR / Reply DR / Esprit DR
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P950029
- Supplement
- S118
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2018-03-11
- Decision code
- APPR
- Date received
- 2018-01-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software updates to the embedded device and remote monitoring system.