FDA.reportPublic FDA data

PMA P170019S013

Device
FoundationOne CDx (F1CDx)
Applicant
Foundation Medicine, Inc.
PMA number
P170019
Supplement
S013
Product code
PQP
Decision date
2020-04-17
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Approval order statement
Approval order for extending the label claim to include an indication for PEMAZYRE(pemigatinib)in cholangiocarcinoma patients with FGFR2 fusions and select rearrangements.

Current openFDA PMA Record#

Device
FoundationOne CDx (F1CDx)
Applicant
Foundation Medicine, Inc.
PMA number
P170019
Supplement
S013
Product code
PQP
Generic name
Next generation sequencing oncology panel, somatic or germline variant detection system
Decision date
2020-04-17
Decision code
APPR
Date received
2019-10-31
Supplement type
Panel Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval order for extending the label claim to include an indication for PEMAZYRE(pemigatinib)in cholangiocarcinoma patients with FGFR2 fusions and select rearrangements.