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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceS670 RAPID EXCHANGE CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP970035
Supplement NumberS015
Date Received04/26/1999
Decision Date11/23/1999
Withdrawal Date10/18/2010
Product Code MAF 
Docket Number N
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The device 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 with reference vessel diameters ranging from 3.0 and 4.0 mm. Long term outcome (beyond 14 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 pressue 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.
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