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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.
Classification Namestent, coronary
Generic Namecardiovascular stent
PMA NumberP970035
Supplement NumberS028
Date Received05/11/2001
Decision Date04/29/2002
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 the thunder high scaffolding over-the-wire (otw) and rapid exchange (rx) saphenous vein graft (svg) stent systems; the addition of a new manufacturing facility, ave ireland limited, galway, ireland; and the addition of a new contract sterilizer, iotron ebis industries uk, ltd. , oxfordshire, united kingdom. The devices, will be marketed under the trade names of the thunder high scaffolding otw and rx svg stent systems, and are indicated for improving vessel luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesions (length <= 40 mm) in saphenous vein grafts with reference vessel diameters between 3. 0 mm and 5. 0 mm. Long term outcome (beyond 6 months) for this permanent implant is unknown at present. The rx delivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressure during the 15-30 second stent deployment procedure only. The rapid exchange stent delivery system is not intended for use as a stand alone ptca perfusion catheter.