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 | CUTTING BALLOON |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | Boston Scientific Corp. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P950020 |
Supplement Number | S003 |
Date Received | 08/20/2001 |
Decision Date | 01/23/2002 |
Product Code |
LOX |
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 THE FOLLOWING MODIFICATIONS TO THE DEVICE: 1) MODIFICATION OF THE DESIGN AND MATERIALS OF CONSTRUCTION OF THE Y-SITE ASSEMBLY; 2) USE OF A COLORANT IN THE GUIDEWIRE LUMEN TUBING; 3) NEW PACKAGING CONFIGURATION AND MATERIALS; AND 4) USE OF AN ALTERNATIVE STERILIZER. |
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