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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 NameQUANTUM MAVERICK MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP860019
Supplement NumberS227
Date Received08/12/2008
Decision Date10/08/2008
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification to the proximal weld process. The device, as modified, will be marketed under the trade name quantum maverick balloon catheters 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. The quantum maverick balloon catheter (balloon models 2. 0 mm ¿ 5. 0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.
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