REPLY/ESPRIT
FDA premarket approval P950029/S060 · decided 2011-08-18
Approval details
- PMA number
- P950029
- Supplement
- S060
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REPLY/ESPRIT
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2011-06-24
- Decision date
- 2011-08-18
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE ADDITION OF THE DPLUS AND ACCELERATION AND ATRIAL VENTRICULAR DELAY REDUCTION PACING MODES ALONG WITH MINOR SOFTWARE UPDATES.
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