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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.
 
DeviceUSCI(R)TELESCOPE(TM) SINGLE OPERATOR BALLOON
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP790017
Supplement NumberS060
Date Received12/17/1996
Decision Date12/15/1997
Reclassified Date10/08/2010
Product Code LOX 
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  
Approval for a new PTCA catheter line. The device, as modified, will be marketed under the trade name USCI(R) Telescope(TM) Single Operator Overl-the-Wire Balloon Catheter with Rely(TM) Balloon Material and Hydro/Pel(R) Coating and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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