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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 NameSEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca system
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP840040
Supplement NumberS051
Date Received09/24/1997
Decision Date11/21/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in adhesive.
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