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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 NameMEDTRONIC(R) MS2(TM) BALLOON SHAPING TOOL
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantMEDTRONICS INTERVENTIONAL VASCULAR
PMA NumberP870036
Supplement NumberS042
Date Received01/29/1997
Decision Date07/28/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an accessory device, the folio balloon shaping tool, to your currently marketed line of medtronic (r) millenia(tm) coronary balloon dilatation catheters.
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