REPLY AND ESPIRIT FAMILY OF PACEMAKERS
FDA premarket approval P950029/S075 · decided 2013-03-13
Approval details
- PMA number
- P950029
- Supplement
- S075
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPLY AND ESPIRIT FAMILY OF PACEMAKERS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-02-19
- Decision date
- 2013-03-13
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR REINFORCEMENT OF AN EXISTING 100% IN-PROCESS SCREENING STEP INTENDED TO BE APPLIED FOR A LIMITED QUANTITY OF THREE (3) IDENTIFIED LOTS.
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