Exact Sciences Corporation- Innovation Campus

Matched from indexed company URL: EXACT SCIENCES CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3008256118	3008256118	Exact Sciences Corporation- Innovation Campus	1	N	2026-01-01	441 Charmany Dr Madison WI US 53719
3013841562	3013841562	Exact Sciences Corporation- Legacy Campus	1	N	2026-01-01	320 Holtzman Road Madison WI US 53713
3015728010	3015728010	Exact Sciences Corporation- Discovery Campus	1	N	2026-01-01	650 Forward Dr Madison WI US 53711

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
232114	1875345745	P230043	Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™	PHP	2024-10-03
173967	1875345745	P230043	Multi-Target Stool DNA (mtsDNA) Test, Cologuard Plus™	PHP	2024-10-03
210404	1648519065	P130017	COLOGUARD	PHP	2014-08-11
232114	1648519065	P130017	COLOGUARD	PHP	2014-08-11
173967	1648519065	P130017	COLOGUARD	PHP	2014-08-11
210404	1603620777
210404	1943601418
210404	1950791953
232114	1603620777
173967	1603620777
173967	1872756884
232114	1872756884
173967	1943601418
232114	1943601418
232114	1950791953
173967	1950791953

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
PHP	3	2014-08-11

PMA#

Cologuard®

2022-08-03

Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS054 Date Received07/11/2022 Decision Date08/03/2022 Product Code PHP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Chang...

Cologuard®

2022-07-19

Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS053 Date Received06/21/2022 Decision Date07/19/2022 Product Code PHP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Chang...

Cologuard®

2022-07-07

Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS052 Date Received06/08/2022 Decision Date07/07/2022 Product Code PHP Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Chang...

Cologuard

2022-04-13

Exact Sciences Corporation441 Charmany Drivemadison, WI 53719 PMA NumberP130017 Supplement NumberS051 Date Received03/02/2022 Decision Date04/13/2022 Product Code PHP Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling ...

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Exact Sciences Corporation- Innovation Campus

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMA#

GUDID#