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 | SOLESTA |
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 | P100014 |
Supplement Number | S007 |
Date Received | 03/30/2012 |
Decision Date | 04/12/2012 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF THE POSSIBILITY TO STORE SAMPLES FOR BIOBURDEN ANALYSIS IN A REFRIGERATOR AT A TEMPERATURE OF 5 DEGREE CELSIUS FOR UP TO 18 HOURS BEFORE ANALYSIS. |
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