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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NamePAS LACROSSE TM PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantPROGRESSIVE ANGIOPLASTY SYSTEMS, INC.
PMA NumberP930012
Supplement NumberS001
Date Received10/04/1995
Decision Date04/02/1996
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of 100% ethylene oxide sterilization to be performed at medical manufacturing corporation, erie, pa.
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