FDA.reportPublic FDA data

American Medical Systems, Inc.

Matched from indexed company URL: AMERICAN MEDICAL SYSTEMS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21839591000116179American Medical Systems, Inc.1N2020-04-2510700 BREN ROAD WEST Minnetonka MN US 55343

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1865981294619430P000053AMS SPHINCTER 800 URINARY CONTROL SYSTEMEZY2001-06-14
1865981442909449N970012AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESESJCW1998-11-02
1865981758669446K090663AMS SPECTRA CONCEALABLE PENILE PROSTHESISFAE2009-04-09
1865981104446946K053371AMS MALE TRANSOBTURATOR SLING SYSTEMOTM2006-02-03
1865981219389659
1865982045997532

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FAE12009-04-09
OTM12006-02-03
EZY12001-06-14
JCW11998-11-02

PMA#

PMN#

81 records. Showing 1-40. Next

GUDID#

72 records. Showing 1-40. Next