|
Device | DEFLUX SYRINGE |
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 | S014 |
Date Received | 10/06/2005 |
Decision Date | 10/28/2005 |
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 IN-PROCESS CONTROL TO REPLACE A TEST PROCEDURE FOR USAGE DURING ORDINARY MANUFACTURING. |
Post-Approval Study | Show Report Schedule and Study Progress |