FDA.reportPublic FDA data

Plexus Manufacturing Sdn. Bhd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30045934953004593495Plexus Manufacturing Sdn. Bhd.1N2026-01-01Bayan Lepas Free Industrial Zone, Phase II Bayan Lepas Pulau Pinang MY 11900

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
85952010436087P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARENVZ1999-01-29
85951107099824K150614Reveal LINQMXD2015-08-06
85951793033570K123597TRUECPR COACHING DEVICELIX2013-04-17
85951051446991K071655REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538DSI2007-11-21
85951549487614K071641REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)DSI2007-11-21
85951067523038
85951144412824
85951155516686
85951208118428
85951212850958
85951245986435
85951251112983
85951317082132
85951352171643
85951372159267
85951451627021
85951534821893
85951535198793
85951633462690
85951654681649
85951694194746
85951750776780
85951809651724
85951858610550
85951873290285
85951881947307
85951888042612
85951903273550
85951932979070
85951936922189
85951982359218
85952015975098
85952048960588
85952069844282

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSI22007-11-21
MXD12015-08-06
LIX12013-04-17
NVZ11999-01-29