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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 | S001 |
Date Received | 10/06/2000 |
Decision Date | 11/01/2000 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN ALTERNATE SUBCONTRACTOR TO HEAT-SEAL THE TRAY LID PACKAGE FOR THE DURASPHERE INJECTABLE BULKING AGENT(R) AND AN ALTERNATE SUPPLIER FOR TYVEC 1078B LID FOR USE BY THE ALTERNATE SUBCONTRACTOR. |