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 | COBAS EGFR MUTATION TEST |
Generic Name | Somatic gene mutation detection system |
Applicant | ROCHE 4300 HACIENDA DRIVE PO BOX 9002 PLEASANTON, CA 94588 |
PMA Number | P120019 |
Supplement Number | S001 |
Date Received | 07/26/2013 |
Decision Date | 08/21/2013 |
Product Code |
OWD |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement CHANGE TO ADD AN ALTERNATE SUPPLIER FOR A CRITICAL RAW MATERIAL. |
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