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 | BARD TEGRESS URETHRAL IMPLANT |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | C.R. Bard, Inc. 13183 HARLAND DRIVE COVINGTON, GA 30014-6421 |
PMA Number | P030030 |
Supplement Number | S002 |
Date Received | 05/04/2005 |
Decision Date | 05/27/2005 |
Withdrawal Date
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04/06/2007 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE AT BARD SHANNON LTD., LAS PIEDRAS, PUERTO RICO, 00771. |
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