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. |
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Device | ROTABLATOR(R) |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. TWO SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P900056 |
Supplement Number | S009 |
Date Received | 12/08/1994 |
Decision Date | 08/14/1995 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN LOCATION FOR SEAMED CORPORATION, THE MANUFACTURER OF THE CONSOLE USED WITH THE ROTABLATOR SYSTE, FROM 11810 NORTH CREEK PARKWAY NORTH, BOTHELL, WASHINGTON, TO WEST WILLOWS TECHNOLOGY CENTER, N.E. 87TH STREET, REDMOND, WASHINGTON |
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