|
Device | DEFLUX INJECTABLE GEL |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | Palette Life Sciences 27 East Cota Street Suite 402 Santa Barbara, CA 93101 |
PMA Number | P000029 |
Supplement Number | S032 |
Date Received | 05/17/2007 |
Decision Date | 10/30/2007 |
Product Code |
LNM |
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 FOR THE REMOVAL OF TWO OF THE VISUAL INSPECTION STEPS IN THE PRODUCTION PROCESS. |