Reply SR, Reply DR, Esprit SR, Esprit DR
FDA premarket approval P950029/S119 · decided 2018-01-29
Approval details
- PMA number
- P950029
- Supplement
- S119
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Reply SR, Reply DR, Esprit SR, Esprit DR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2018-01-05
- Decision date
- 2018-01-29
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Add a new supplier for silicone cap components for use in the device header.
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