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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHEPACOAT ON BX SONIC BALLOON-EXPANDABLE STENT OTW DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namecoronary stent and delivery system
ApplicantCORDIS CORP.
PMA NumberP900043
Supplement NumberS035
Date Received02/19/2002
Decision Date08/02/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification of the indications for the hepacoat on bx sonic balloon-expandable stent otw delivery system. The device, as modified, is indicated for improving coronary luminal diameter in the following: 1) for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (<=30 mm in length) in native coronary arteries with reference diameters ranging from 3. 0 mm to 5. 0 mm involving direct stenting or predilatation; and 2) for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (<=30 mm in length) with reference diameters in the range of 2. 25 mm to 4. 0 mm. The 2. 25 mm, 2. 5 mm, and 2. 75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4. 5 and 5. 0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.
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