FDA.reportPublic FDA data

SHIRE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30093406443009340644SHIRE HUMAN GENETIC THERAPIES, INC.1Y2026-01-01300 SHIRE WAY Lexington MA US 02421
30150542583015054258SHIRE HUMAN GENETIC THERAPIES, INC.1N2026-01-011445 Lawrence Drive Thousand Oaks CA US 91320
30129621383012962138SHIRE HUMAN GENETIC THERAPIES, INC.1Y2020-04-25730 Stockton Drive Exton PA US 19341

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2239001573949741K121092FLOWEASE [SUBCUTANEOUS] INFUSION SETFPA2012-06-29
1924731573949741K121092FLOWEASE [SUBCUTANEOUS] INFUSION SETFPA2012-06-29
1924731886771087K092318BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICELHI2009-10-30
2239001886771087K092318BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICELHI2009-10-30
1924731189084483K070100HASELMEIER PENFMF2007-03-21
2018481189084483K070100HASELMEIER PENFMF2007-03-21
1924731971395616K042410BAXJECT IILHI2004-10-08
2239001971395616K042410BAXJECT IILHI2004-10-08
1924731885639457K031861MIX2VIAL TRANSFER DEVICELHI2003-07-29
2018481885639457K031861MIX2VIAL TRANSFER DEVICELHI2003-07-29
1924731168314506
2018481168314506
1924731289505451
2239001778251948
1924731778251948
2018481927974842
1924731927974842
2239001289505451
2239001329566561

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LHI62009-10-30
FPA22012-06-29
FMF22007-03-21

PMA#

TRANSCYTE

2004-06-28

SHIRE REGENERATIVE MEDICINE

TRANSCYTE

2000-03-16

SHIRE REGENERATIVE MEDICINE

TRANSCYTE

1999-11-26

SHIRE REGENERATIVE MEDICINE

TRANSCYTE

1998-08-14

SHIRE REGENERATIVE MEDICINE

Applications#

GUDID#