REPLY DR/SR
FDA premarket approval P950029/S046 · decided 2009-07-15
Approval details
- PMA number
- P950029
- Supplement
- S046
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REPLY DR/SR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2009-06-17
- Decision date
- 2009-07-15
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE ADDITION OF AN INSPECTION STEP TO CHECK FOR EXCESSIVE SILICONE ADHESIVE IN THE SET SCREW CAVITY.
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