S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
FDA premarket approval P020036 · decided 2003-08-12
Approval details
- PMA number
- P020036
- Trade name
- S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
- Generic name
- STENT, ILIAC
- Applicant
- Cordis US Corporation
- Date received
- 2002-09-05
- Decision date
- 2003-08-12
- Days to decision
- 341 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE S.M.A.R.T. NITINOL STENT SYSTEM AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM. THE DEVICES ARE INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 4 TO 9 MM, AND ANGIOGRAPHIC EVIDENCE OF A PATIENT PROFUNDA OR SUPERFICIAL FEMORAL ARTERY.
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