CORDIS PRECISE NITINOL & RX NITINOL & PRO RX NITINOL STENT SYSTEM
FDA premarket approval P030047/S005 · decided 2007-09-20
Approval details
- PMA number
- P030047
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CORDIS PRECISE NITINOL & RX NITINOL & PRO RX NITINOL STENT SYSTEM
- Generic name
- Stent, carotid
- Applicant
- Cordis US Corporation
- Date received
- 2007-08-27
- Decision date
- 2007-09-20
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE ESTABLISHMENT OF AN ADDITIONAL SPECIFICATION FOR A BISMUTH SUBCARBONATE BLEND RAW MATERIAL.
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