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 | PTCA CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | BOSTON SCIENTIFIC One Scimed Place Maple Grove, MN 55311 |
PMA Number | P880027 |
Supplement Number | S064 |
Date Received | 03/14/2005 |
Decision Date | 10/31/2005 |
Withdrawal Date
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04/13/2007 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER (EDC), KERKRADE, THE NETHERLANDS. THIS FACILITY WILL RELABEL AND PACKAGE VARIOUS STENTS AND PTCA CATHETERS. |
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