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PMA P990081S046

Device
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
Applicant
Ventana Medical Systems, Inc.
PMA number
P990081
Supplement
S046
Product code
MVC
Decision date
2022-07-21
Generic name
SYSTEM, TEST, HER-2/NEU, IHC
Approval order statement
Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.

Current openFDA PMA Record#

Device
PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody
Applicant
Ventana Medical Systems, Inc.
PMA number
P990081
Supplement
S046
Product code
MVC
Generic name
SYSTEM, TEST, HER-2/NEU, IHC
Decision date
2022-07-21
Decision code
APPR
Date received
2022-02-16
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II.