REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR Pacemakers
FDA premarket approval P950029/S110 · decided 2016-06-22
Approval details
- PMA number
- P950029
- Supplement
- S110
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR Pacemakers
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2016-05-27
- Decision date
- 2016-06-22
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Use of Automated Optical Inspection in a portion of the final electrical assembly visual inspection.
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