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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.
 
DeviceROTABLATOR(R) ROTALINK ROTATIONAL ANGIOPLASTY SYSTEM AND ROTALINK(TM) PLUS WITH EXCHANGEABLE CATHETER
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
Two Scimed Pl.
Maple Grove, MN 55311
PMA NumberP900056
Supplement NumberS060
Date Received02/06/2001
Decision Date03/21/2001
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC CORK LTD. (BSCL), CORK, IRELAND AND A STERILIZATION FACILITY LOCATED AT ISOTRON IRELAND LTD., OFFALY, IRELAND.
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