REPLY & ESPRIT SR & DR Pacemakers
FDA premarket approval P950029/S117 · decided 2018-01-29
Approval details
- PMA number
- P950029
- Supplement
- S117
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPLY & ESPRIT SR & DR Pacemakers
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2018-01-03
- Decision date
- 2018-01-29
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Modify the gluing process of the silicone caps, X-ray tag, and header cavities and to move the assembly sequence of the bal seal springs for the header.
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