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 | CORDIS TITAN & TITAL XL DILATION CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014-5700 |
PMA Number | P880003 |
Supplement Number | S071 |
Date Received | 07/17/1997 |
Decision Date | 08/04/1998 |
Reclassified Date
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10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new indication for use: the post-delivery expansion of the Palmaz-Schatz(TM) Coronary Stet, with the Titan(TM) and Tita(TM) XL PTCA Dilatation Catheters (3.0 mm, 3.25 mm, 3.5mm, 3.75 mm balloon diamters with 9 mm and 18 mm balloon lengths, and a 4.0 mm balloon diameter with 9 mm balloon length.) |
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