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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.
 
DeviceSCIMED QUANTUM RANGER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantScimed Life Systems, Inc.
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP860019
Supplement NumberS142
Date Received04/06/1998
Decision Date05/13/1998
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to extend the product line of the SCIMED(R) NC Ranger(TM) PTCA Catheter to include a 9 mm length balloon with diameters ranger from 2.5 mm to 4.0 mm in 0.25 mm increments. The device, as modified, will be marketed under the trade name SCIMED(R) 9 mm NC Ranger(TM) PTCA Catheter 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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