Pacemakers Reply SR/DR and Esprit SR/DR
FDA premarket approval P950029/S120 · decided 2018-03-15
Approval details
- PMA number
- P950029
- Supplement
- S120
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Pacemakers Reply SR/DR and Esprit SR/DR
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2018-02-16
- Decision date
- 2018-03-15
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Implementation of manufacturing changes on Zener diodes used in the electronic hybrid module in the Reply and Esprit families of pacemakers.
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