|
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 | S019 |
Date Received | 09/05/2006 |
Decision Date | 04/26/2007 |
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 TWO NEW WATER SYSTEMS (FOR THE PRODUCTION OF PURIFIED WATER (PW) AND FOR WATER FOR INJECTION (WFI)) AND THE EQUIPMENT FOR THE PRODUCTION, STORAGE AND DISTRIBUTION OF PW AND WFI. |