|
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 |
Supplement Number | S004 |
Date Received | 05/18/2006 |
Decision Date | 08/23/2006 |
Product Code |
FAF |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO ADD BLACK INK TO IMPROVE THE VISIBILITY OF THE SERIAL NUMBERS. |