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 | DURASPHERE EXP |
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 | S007 |
Date Received | 06/29/2004 |
Decision Date | 10/27/2004 |
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 1 ML SYRINGES WITH SYNTHETIC RUBBER STOPPERS. THESE SYRINGES ARE INTENDED TO STORE DURASPHERE EXP. |
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