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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.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
PMA NumberP870036
Supplement NumberS043
Date Received03/03/1997
Decision Date08/12/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: a) the additio of 15 mm lengths to the millenia(tm) coronary balloon dilatation catheter line; b) a change in the method used to test for burst strength of the balloons; and c) the addition of the folio balloon shaping tool as an accessory. The device, as modified, will be marketed under the trade name medtronic(r) millenia(tm) 15 coronary balloon dilatation 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.