REPLY DR, REPLY SR, ESPRIT DR, ESPRIT SR
FDA premarket approval P950029/S105 · decided 2016-06-24
Approval details
- PMA number
- P950029
- Supplement
- S105
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REPLY DR, REPLY SR, ESPRIT DR, ESPRIT SR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2015-03-30
- Decision date
- 2016-06-24
- Days to decision
- 452 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for hardware modifications to the REPLY/ESPRIT pacemaker platform.
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