PMA P990001S068

Device: DEMA IPG/C & T SERIES IPGS
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S068
Product code: NVZ
Decision date: 2011-03-22
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.

Current openFDA PMA Record

Device: DEMA IPG/C & T SERIES IPGS
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S068
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2011-03-22
Decision code: APPR
Date received: 2010-05-17
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CHANGE OF THE MATERIALS, POWER SUPPLY, AND INCOMING INSPECTIONPROCESS FOR THE FOLLOWING AVX CAPACITORS TO BE USED IN THE ABOVE REFERENCED IPGS. THOSE CAPACITORS ARE: XT009, XT045, XT082, XT096, XT113, XTC002, XTC018, XTC029, XT014,XT053, XT084, XT097, XT114, XTC004, XTC019, XTC030, XT017, XT058, XT085, XT099,XT116, XTC005, XTC020, XT023, XT060, XT086, XT103, XT118, XTC006, XTC021,XT027, XT067, XT087, XT104, XT120, XTC007, XTC023, XT032, XT068, XT088, XT105,XT121, XTC008, XTC024, XT038, XT070, XT090, XT106, XT122, XTC009, XTC025,XT041, XT072, XT091, XT108, XT123, XTC010, XTC026, XT043, XT077, XT092, XT109,XT124, XTC013, XTC027, XT044, XT078, XT095, XT110, XTC001, XTC017, XTC028,XT097, XT118, XT009, XT017, XT044, XT070, XT085, XT087, AND XT114.