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 | Oncomine Dx Target Test |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | LIFE TECHNOLOGIES CORPORATION 5781 VAN ALLEN WAY CARLSBAD, CA 92008 |
PMA Number | P160045 |
Supplement Number | S010 |
Date Received | 10/09/2018 |
Decision Date | 10/30/2018 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Supplier change of critical raw material used in Ion OneTouch Dx Template Kits. |
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