REPLY/ESPRIT
FDA premarket approval P950029/S055 · decided 2010-12-15
Approval details
- PMA number
- P950029
- Supplement
- S055
- 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
- 2010-11-03
- Decision date
- 2010-12-15
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- CHANGE IN THE REFLOW SOLDERING AND CLEANING PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.