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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 NameS7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLO0N
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP970035
Supplement NumberS038
Date Received04/23/2002
Decision Date10/15/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following trade names and expanded device indications: the s7 with discrete technology over-the-wire coronary stent system with the av2000 balloon is indicated for: "improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length <=30 mm) in native coronary arteries and saphenous vein grafts with reference vessel diameters ranging from 3. 0 mm to 4. 0 mm through direct stenting or predilatation. Long-term outcome (beyond 180 days) for this permanent implant is unknown at present. " the s7 with discrete technology over-the-wire coronary stent system with the av100 balloon is indicated for: "improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length <=30 mm) in native coronary arteries and saphenous vein grafts with reference vessel diameters ranging from 3. 0 mm to 4. 0 mm through direct stenting or predilatation. Long-term outcome (beyond 180 days) for this permanent implant is unknown at present. " the s7 with discrete technology rapid exchange coronary stent system with the av2000 balloon is indicated for: "improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length <=30 mm) in native coronary arteries and sapheous vein grafts with reference vessel diameters ranging from 3. 0 mm to 4. 0 mm through direct stenting or predilatation. Long-term outcome (beyond 180 days) for this permanent implant is unknown at present. The rapid exchange 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. " the s7 with discrete technology rapid exchange coronary stent system with the av100 balloon is indicated for: "improving coronary luminal diameter in patients with.
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