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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSPOT-LIGHT HER2 CISH KIT
Generic NameChromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
Regulation Number864.1890
ApplicantInvitrogen Corporation
3175 Staley Rd.
Grand Island, NY 14072
PMA NumberP050040
Supplement NumberS002
Date Received03/01/2011
Decision Date04/29/2011
Withdrawal Date01/07/2015
Product Code NYQ 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES IN THE PRODUCT INSERT: 1) MANUFACTURING ADDRESS CHANGE; 2) COPYRIGHT CHANGE FROM INVITROGEN CORPORATION TO LIFE TECHNOLOGIES. INVITROGEN WILL REMAIN THE BRAND NAME AND THEREFORE IS STILL INCLUDED ON THE PRODUCT INSERT AND LABELING; AND AN ADDITION OF LITERATURE REFERENCES TO THE BIBLIOGRAPHY.
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