PMA P100027S036

Device: INFORM HER2 Dual ISH DNA Probe Cocktail
Applicant: Ventana Medical Systems, Inc.
PMA number: P100027
Supplement: S036
Product code: NYQ
Decision date: 2022-07-21
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
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: INFORM HER2 Dual ISH DNA Probe Cocktail
Applicant: Ventana Medical Systems, Inc.
PMA number: P100027
Supplement: S036
Product code: NYQ
Generic name: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer
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.