REPLY DR/SR & REPLY DR/SR (V2)/ESPRIT DR/SR
FDA premarket approval P950029/S054 · decided 2010-08-18
Approval details
- PMA number
- P950029
- Supplement
- S054
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPLY DR/SR & REPLY DR/SR (V2)/ESPRIT DR/SR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2010-07-19
- Decision date
- 2010-08-18
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR ADDING A REINFORCED INSPECTION STEP TO THE MANUFACTURING PROCESS OF THE DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.