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 | MACROPLASTIQUE IMPLANTS |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | UROPLASTY, LLC 5420 FELTL ROAD MINNETONKA, MN 55343 |
PMA Number | P040050 |
Supplement Number | S003 |
Date Received | 02/18/2009 |
Decision Date | 06/26/2009 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING MODIFICATIONS TO REFLECT THE FINDINGS OF THE ENHANCED SURVEILLANCE STUDY. |
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