CORDIS S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036/S008 · decided 2007-09-20
Approval details
- PMA number
- P020036
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CORDIS S.M.A.R.T. NITINOL STENT SYSTEM & S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2007-08-24
- Decision date
- 2007-09-20
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- NIO
- 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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