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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Trade NamePRIME{TM} MODEL 6520, 6525, 6530 AND 6535
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecoronary balloon dilatation catheters
Regulation Number870.5100
PMA NumberP870021
Date Received05/05/1987
Decision Date02/29/1988
Reclassified Date 10/08/2010
Product Code
LOX[ Registered Establishments with LOX ]
Docket Number 88M-0106
Notice Date 05/11/1988
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004