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 | INFORM HER-2/NEU |
Generic Name | SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. TUCSON, AZ 85755 |
PMA Number | P940004 |
Supplement Number | S001 |
Date Received | 07/10/2000 |
Decision Date | 08/01/2000 |
Withdrawal Date
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10/22/2007 |
Product Code |
MVD |
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 RAW MATERIAL SUBSTITUTION OF REPLACING NONIDET P-40, RAW MATERIAL WITH IGEPAL CA-630, AND CHANGES FOR THE USE OF DRY POWDERS OR SOLUTIONS THAT ARE PURCHASED RATHER THAN MANUFACTURED WHILE KEEPING THE FINAL FORMULATION AND SPECIFICATIONS THE SAME. |
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