Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | COLOPLAST SALINE-FILLED TESTICULAR PROSTHESIS |
Generic Name | Prosthesis, testicular |
Regulation Number | 876.3750 |
Applicant | COLOPLAST CORP. 1601 WEST RIVER ROAD NORTH MINNEAPOLIS, MN 55411 |
PMA Number | P020003 |
Date Received | 01/22/2002 |
Decision Date | 07/19/2002 |
Product Code |
FAF |
Docket Number | 02M-0322 |
Notice Date | 08/06/2002 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MENTOR SALINE-FILLED TESTICULAR PROSTHESIS. THE DEVICE IS INDICATED FOR USE WHEN COSMETIC TESTICULAR REPLACEMENT IS INDICATED; I.E., IN THE CASE OF AGENESIS OR FOLLOWING THE SURGICAL REMOVAL OF A TESTICLE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
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