REPLY/ESPRIT
FDA premarket approval P950029/S065 · decided 2012-02-02
Approval details
- PMA number
- P950029
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPLY/ESPRIT
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2012-01-05
- Decision date
- 2012-02-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- ADDITIONAL OVEN, AN UPDATED CLEANING PROCESS, AND AN UPDATE TO THE REWORK PROCESS.
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