REPLY SR,REPLY DR,ESPRIT SR,ESPRIT DR
FDA premarket approval P950029/S083 · decided 2013-09-26
Approval details
- PMA number
- P950029
- Supplement
- S083
- Supplement type
- 30-Day Notice
- Trade name
- REPLY SR,REPLY DR,ESPRIT SR,ESPRIT DR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2013-09-11
- Decision date
- 2013-09-26
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CHANGE IN THE TEST METHODOLOGY EMPLOYED DURING BENCH TESTING OF THE COMPONENTS AND FINISHED DEVICE.
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