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Device | DURASPHERE INJECTABLE BULKING AGENT |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. ST. PAUL, MN 55110-5876 |
PMA Number | P980053 |
Supplement Number | S008 |
Date Received | 12/22/2004 |
Decision Date | 09/26/2005 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE 1 ML SYRINGE USED TO DEPLOY DURASPHERE INJECTABLE BULKING AGENT TO BE CHANGED FROM A POLYCARBONATE SYRINGE WITH THE LATEX-FREE COMPOUND TIP TO A SYRINGE WITH A POLYPROPYLENE SILICONE TIP. |