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 | ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEN |
Generic Name | CATHETER, CORONARY, ATHERECTOMY |
Applicant | Boston Scientific Corp. One Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P980037 |
Supplement Number | S024 |
Date Received | 12/20/2007 |
Decision Date | 06/17/2008 |
Product Code |
MCX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ALTERNATIVE HYDROPHILIC COATING MATERIAL AND SUPPLIER (DSM BIOMEDICAL, GLEEN, NETHERLANDS) USED ON THE DISTAL SHAFT OF THE SPIROFLEX FAMILY OF CATHETERS (SPIROFLEX AND SPRIOFLEX VG) AND APPROVAL TO PERFORM THE MANUFACTURING COATING PROCESS OF THE NEW DSM HYDROPHILIC COATING AT THE POSSIS FACILITY, MINNEAPOLIS, MINNESOTA. |
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