FDA.reportPublic FDA data

Marsha Seetaram

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
97101073003348376Marsha Seetaram1N2027-01-01710 Medtronic Pkwy Minneapolis MN US 55432
96157423003521774Marsha Seetaram1N2026-01-0115 Hampshire Street Mansfield MA US 02048

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1217611919697510K992556PERMACOLFTL2000-02-17
1217611772844903K982532PARIETEXFTL1999-01-20
1217612001638227K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)FTL2026-05-21
1217611486322307K253125Parietene™ Flat Sheet MeshFTL2025-10-24
1217611846945645K250869Parietene™ Macroporous Mesh (PPM5050 )FTL2025-04-23
1217611863197040K243315ProGrip™ Self-Gripping Polypropylene MeshFTL2025-01-17
3321811519345671K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareNEZ2024-05-10
1217611283443896K233661Transorb™ Self-Gripping Resorbable MeshOWT2024-02-13
1217611318805050K232373Progrip™ Self-Gripping Polypropylene MeshFTL2024-01-18
3321811200810190K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ENEZ2023-06-30
1217611205025956K223218Parietene Macroporous MeshFTL2022-12-02
1217612031863469K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament MeshFTL2022-06-22
1217611978092625K220540ProGrip Self-Gripping Polypropylene MeshFTL2022-09-22
3321811302954467K211684PillCam SB 3 capsule endoscopy system, PillCam Software 9.0ENEZ2021-08-27
1217611126543081K192443Dextile Anatomical MeshFTL2019-12-06
1217611835088982K192443Dextile Anatomical MeshFTL2019-12-06
3321811752001067K180171PillCam Patency SystemNSI2018-03-08
1217611769170237K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)FTL2018-03-09
1217611607959500K172395Duatene bilayer meshFTL2018-02-01
3321811510827414K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0NEZ2017-09-01
1217611727925386K163212Parietene DS Composite MeshFTL2017-06-29
3321811054419567K153466PillCam COLON 2 Capsule Endoscopy SystemPGD2016-01-14
3321811993921557K151086ManoScan SystemFFX2016-04-28
1217611022538783K150091Versatex Monofilament MeshFTL2015-05-26
1217611643844412K150091Versatex Monofilament MeshFTL2015-05-26
1217611063757451K143386Progrip Laparoscopic Self-Fixating MeshFTL2015-03-13
1217611970958380K143386Progrip Laparoscopic Self-Fixating MeshFTL2015-03-13
1217611471470872K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite MeshFTL2014-11-14
1217611481316286K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite MeshFTL2014-11-14
1217611287457326K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating MeshFTL2014-10-28
1217611391101864K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating MeshFTL2014-10-28
1217611475485913K142091PARIETENE MACROPOROUS MESHFTL2014-10-17
1217611554169571K142091PARIETENE MACROPOROUS MESHFTL2014-10-17
3321811280280542K140284GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEMNEZ2014-12-17
1217611629228299K131969SYMBOTEX(TM) COMPOSITE MESHFTL2013-08-22
1217611727303640K131969SYMBOTEX(TM) COMPOSITE MESHFTL2013-08-22
3321811967077710K123864GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEMNEZ2013-08-12
1217611623752018K123479PROGRIP LAPAROSCOPIC SELF-FIXATING MESHFTL2012-12-11
1217611694499199K120897PROGRIP LAPARSCOPIC SELF-FIXATING MESHFTL2012-06-29
1217611204148640K120605PERMACOL SURGICAL IMPLANTFTM2012-05-18
1217611709936692K120506PARIETEX COMPOSITE VENTRAL PATCHFTL2012-06-13
1217611657738551K110816PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)FTL2011-04-19
1217611022109096K110815PARIETEX OPTIMIZED COMPOSTIE MESHFTL2011-04-19
1217611187111384K110663PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)FTL2011-08-11
1217611719806374K103682PARIETEX PROGRIPFTL2011-03-04
3321811088392787K102543BRAVO PH MONITORING SYSTEM AND ACCESSORIESFFT2010-12-01
1217611291302364K101519PARIETEX PLUG AND PATCHFTL2010-11-05
3321811751524723K092342SMARTPILL GI MONITORING SYSTEM, VERSION 2.0NYV2009-10-30
1217611939779990K090858PARIETEX MONOFILAMENT POLYESTER MESHFTL2009-05-06
1217611393034684K081126PARIETEX COMPOSITE MONO PM MESHFTL2008-08-13
1217611097509745K081050PARIETEX PROGRIP MESHFTL2008-05-28
1217611165201937K050187PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHESFTL2005-02-18
1217611693402944K043366PERMACOL SURGICAL IMPLANTFTL2004-12-17
1217611614555922K040998MODIFICATION TO PARIETEX COMPOSITE (PCO) MESHFTL2004-04-29
1217611560622013K013625PERMACOLFTM2002-01-17
1217611877877099K002699PARIETEX COMPOSITE (PCO) MESHFTL2001-02-15
3321811319270287

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FTL482026-05-21
NEZ62024-05-10
FTM42012-05-18
OWT12024-02-13
NSI12018-03-08
FFX12016-04-28
PGD12016-01-14
FFT12010-12-01
NYV12009-10-30