Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S002 |
Date Received | 11/22/2002 |
Decision Date | 12/18/2002 |
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 CHANGE IN SITE FOR BACTERIAL ENDOTOXIN TESTING FOR THE DEFLUX NEEDLE, A COMPONENT OF THE DEFLUX DEVICE. THE TESTING IS CURRENTLY CONDUCTED AT A CONTRACT FACILITY, NAMSA, AND WILL BE MOVED TO Q-MED'S MICROBIOLOGY QC LABORATORY IN UPPSALA, SWEDEN. THERE WILL ALSO BE A CHANGE OF TEST METHOD FROM KINETIC-CHROMOGENIC LAL PROCEDURE TO THE GEL CLOT LAL TEST. |
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