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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.
 
DeviceS7 WITH DISCRETE TECHNOLOGY OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEM WITH THE AV2000 BALLO0N
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
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/instructions/shelf life/tradename
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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