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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 NumberS049
Date Received09/05/1995
Decision Date10/19/1995
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type 30-Day Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised labeling to address our ptca labeling letter of january 7, 1995, and change the corporate name on your labeling from mansfield/boston scientific corporation to scimed/boston scientific corporation.
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