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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 NameOVER THE WIRE DILATATION CATHETERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantC.R. BARD IRELAND, LTD.
PMA NumberP790017
Supplement NumberS068
Date Received12/10/1998
Decision Date01/08/1999
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested to modify the sterilization parameters to address the excessively long ethylene oxide residue quarantine times by reducing as exposure minor modifications to the sterilization parameters are also being introduced to improve efficiency and increase flexibility at the contract sterilization facility.
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