Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·(QON) InterStim® Therapy System, Verify® Evaluation System

InterStim™ SureScan™

FDA UDI

MEDTRONIC, INC.·00763000596910·LEAD 978B128 ISTM SSMRI 4.32MM EMAN GLBL

Axonics

FDA UDI

AXONICS MODULATION TECHNOLOGIES, INC.·10810005340479·Neurostimulator

INTERSTIM®

FDA UDI

MEDTRONIC, INC.·00613994925947·LEAD 305901 PNE TEST STIM LEAD EMAN

INTERSTIM®

FDA UDI

MEDTRONIC, INC.·20643169721153·NEEDLE 041829 5 INCH GLOBAL FLEX

INTERSTIM®

FDA UDI

MEDTRONIC, INC.·20643169721207·CABLE 357937 ISTM TEST NO GP 6PK FM OTAY

NA

FDA UDI

MEDTRONIC, INC.·00763000826000·COMM HANDSET TH90QFA ISTIM X EMAN US

INTERSTIM®

FDA UDI

MEDTRONIC, INC.·20613994926306·GROUND PAD 041826 GLOBAL FLEX

INTERSTIM®

FDA UDI

MEDTRONIC, INC.·20643169721214·CABLE 357975 ISTM TEST NO GP 6PK FM OTAY

InterStim iCon

FDA UDI

MEDTRONIC, INC.·00613994639639·PROGRAMMER 3037 INTERSTIM PATIENT BOWEL

NA

FDA UDI

MEDTRONIC, INC.·00763000825997·COMM HANDSET TH90Q01 ISTIM X EMAN US

INTERSTIM®

FDA UDI

MEDTRONIC, INC.·00643169013438·EXT 3095-51 QD INLINE 51CM BWL MRI-HC US

INTERSTIM®

FDA UDI

MEDTRONIC, INC.·00643169346260·EXT 3095-25 QD INLNE 25CM BWL MRI-HC EMN

InterStim™ Micro SureScan™ MRI

FDA UDI

MEDTRONIC, INC.·00763000596736·INS 97810 ISTM MICRO SSMRI RC EMAN US

InterStim iCon®

FDA UDI

MEDTRONIC, INC.·00643169518940·PROG 3037 INTRSTIM II PATIENT ROHS

INTERSTIM®

FDA UDI

MEDTRONIC, INC.·20763000060286·CABLE 041831 PAT SCREEN INTERSTIM US

INTERSTIM®

FDA UDI

MEDTRONIC, INC.·00643169021457·LEAD 309101 PNE TEST STIM KIT EMAN US

NA

FDA UDI

MEDTRONIC, INC.·00763000875848·RECHARGER WR9220-SVC WIRELESS PH SRVC US

INTERSTIM

FDA UDI

MEDTRONIC, INC.·00613994571946·EXTN 3095-51 KIT QD INLINE US 51CM BOWEL

NA

FDA UDI

MEDTRONIC, INC.·00613994100955·Extension, 3095-25,InterStim, US, 25cm