Reply SR / Esprit SR / Reply DR / Esprit DR
FDA premarket approval P950029/S118 · decided 2018-03-11
Approval details
- PMA number
- P950029
- Supplement
- S118
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Reply SR / Esprit SR / Reply DR / Esprit DR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2018-01-03
- Decision date
- 2018-03-11
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for software updates to the embedded device and remote monitoring system.
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