PMA P940004S001

Device: INFORM HER-2/NEU
Applicant: Ventana Medical Systems, Inc.
PMA number: P940004
Supplement: S001
Product code: MVD
Decision date: 2000-08-01
Generic name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
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.

Current openFDA PMA Record

Device: INFORM HER-2/NEU
Applicant: Ventana Medical Systems, Inc.
PMA number: P940004
Supplement: S001
Product code: MVD
Generic name: SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
Decision date: 2000-08-01
Decision code: OK30
Date received: 2000-07-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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.