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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.
 
DeviceUSCI(R)BALLOON DILATATION CATH. W/PETELITE(TM)
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
Applicant
MEDTRONIC IRELAND
parkmore business park west
galway 
PMA NumberP790017
Supplement NumberS049
Date Received12/23/1992
Decision Date02/26/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MANUFACTURING CHANGES TO THE BALLOON AND INCLUDED THE USE OF A BALLOON PROTECTOR. THE DEVICES, AS MODIFIED, WILL BE MARKETED WITH THE PETELITE BALLOON DESIGNATION
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