REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR
FDA premarket approval P950029/S096 · decided 2015-01-06
Approval details
- PMA number
- P950029
- Supplement
- S096
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-10-09
- Decision date
- 2015-01-06
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR DESIGN CHANGES TO AND AN ALTERNATE SUPPLIER FOR THE G-SENSOR COMPONENT USED IN THE ACCELEROMETER OF THE REPLY AND ESPRIT PACEMAKERS.
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