FDA.reportPublic FDA data

Roberta Bogenschutz

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30149189773014918977Roberta Bogenschutz1N2027-01-011225 Old Hwy 8 NW St. Paul MN US 55117

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2237881072781342P240042Tendyne Transcatheter Mitral Valve SystemNPU2025-05-23
2237881772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
2237881317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
2237881259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
2237881469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
2237881437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
2237881720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
2237881527443772
2237881614839080
2237881882814070

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LWR22011-04-20
NPT 12021-09-17
NGV 12021-08-14
MAE12003-05-14
MLV12001-12-05