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. |
|
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 | S006 |
Date Received | 03/07/2003 |
Decision Date | 08/26/2003 |
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 A MODIFIED BEAD SPECIFICATION (90-212 UM) FOR THE PYROLYTIC CARBON COATED ZIRCONIUM OXIDE AND GRAPHITE BEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DURASPHERE EXP AND IS INDICATED FOR USE IN THE TREATMENT OF ADULT WOMEN WITH STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD). |
|
|