FDA.reportPublic FDA data

MEDINOL LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
97102843003084171MEDINOL LTD.1N2027-01-01KIRYAT ATIDIM, BLDG. 8 TEL-AVIV Tel Aviv IL 6158101
30030841713003182398MEDINOL LTD.1N2027-01-018 Hartom Street Beck Tech Bldg. Har Hotzvim B, Jerusalem IL 9777508

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07290107013529EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R12US(800) 327-7714GMB-CORDIS-CUSTOMER-SUPPORT@ca
07290107013529EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R12US(800) 327-7714GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
07290107013529EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R12US(720) 386 5585customerservice@medinol.com
07290107013536EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R15US(800) 327-7714GMB-CORDIS-CUSTOMER-SUPPORT@ca
07290107013536EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R15US(800) 327-7714GMB-CORDIS-CUSTOMER-SUPPORT@cardinalhealth.com
07290107013536EluNIR Ridaforolimus Eluting Coronary Stent System - LUN250R15US(720) 386 5585customerservice@medinol.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1691541242808008P170008EluNIR™ Ridaforolimus Eluting Coronary Stent SystemNIQ2017-11-28
172931242808008P170008EluNIR™ Ridaforolimus Eluting Coronary Stent SystemNIQ2017-11-28
172931682316884P110004PRESILLION PLUS COCR CORONARY STENT RX SYSTEMMAF2012-04-12
1691541682316884P110004PRESILLION PLUS COCR CORONARY STENT RX SYSTEMMAF2012-04-12
172931554837835K173581Gallant PTCA Dilatation CatheterLOX2018-01-25
1691541554837835K173581Gallant PTCA Dilatation CatheterLOX2018-01-25
1691541715143544K162434NC Gallant PTCA CatheterLOX2017-01-19
172931715143544K162434NC Gallant PTCA CatheterLOX2017-01-19
172932014441856K081956MEDINOL X-SUIT NIR BILIARY METALLIC STENTFGE2009-01-09
1691542014441856K081956MEDINOL X-SUIT NIR BILIARY METALLIC STENTFGE2009-01-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOX42018-01-25
NIQ22017-11-28
MAF22012-04-12
FGE22009-01-09

PMA#

PMN#

GUDID#

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