PMA P160045S035

Device: Oncomine Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S035
Product code: PQP
Decision date: 2022-08-11
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement: Approval to expand the indications for use to include a companion diagnostic indication for the detection of ERBB2 activating mutations (SNVs and exon 20 insertions) in non-small cell lung cancer patients who may benefit from treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki).

Current openFDA PMA Record#

Device: Oncomine Dx Target Test
Applicant: Life Technologies Corporation
PMA number: P160045
Supplement: S035
Product code: PQP
Generic name: Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date: 2022-08-11
Decision code: APPR
Date received: 2022-03-08
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to expand the indications for use to include a companion diagnostic indication for the detection of ERBB2 activating mutations (SNVs and exon 20 insertions) in non-small cell lung cancer patients who may benefit from treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki).