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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.
 
DeviceMICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP970035
Supplement NumberS012
Date Received12/11/1998
Decision Date12/29/1998
Withdrawal Date10/18/2010
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The 30-Day Notice requested to add an additional step in the manufacturing of multilumen tubing. The additional step would consist of compounding the virgin resin HDPE/Black-Colorant blend prior to the extrusion of multilumen tubing by AVE. The compounding will be done by a vendor via machine mixing, extruded and then re-pelletized to provide compounded resin pellets of the blend required for extrusion of AVE's multilumen tubing.
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