REPLY SR, REPLY DR, ESPIRIT SR, ESPRIT DR
FDA premarket approval P950029/S097 · decided 2014-10-23
Approval details
- PMA number
- P950029
- Supplement
- S097
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- REPLY SR, REPLY DR, ESPIRIT SR, ESPRIT DR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2014-10-01
- Decision date
- 2014-10-23
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE IMPLANT MANUALS IN ALIGNMENT WITH A PREVIOUS SAFETY COMMUNICATION.
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