PMA P990001S080

Device: VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S080
Product code: NVZ
Decision date: 2011-03-22
Generic name: Pulse generator, permanent, implantable
Approval order statement: APPROVAL FOR THE DESIGN CHANGES TO THE MULTILAYER CERAMIC CAPACITORS (XC308, XC251, XC259, AND XC263) FOR CONCERTO II MODEL D274TRK; CONSULTA MODEL D224TRK; AND MAXIMO II MODELD284TRK; MAXIMO II MODELS D284DRG, D2S4VRC; SECURA MODELS D224DRG, D224VRC; ANDVIRTUOSO MODELS D274DRG. D274VRG; ENRHYTHM MODEL P1501DR; VITATRON DA+ C- SERIES MODELS C20A1, C20A3, C60A1, C60A3; AND VITATRON DA+ T-SERIES MODELS T2OA1, T6OA1;

Current openFDA PMA Record#

Device: VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES
Applicant: Medtronic, Inc.
PMA number: P990001
Supplement: S080
Product code: NVZ
Generic name: Pulse generator, permanent, implantable
Decision date: 2011-03-22
Decision code: APPR
Date received: 2010-12-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE DESIGN CHANGES TO THE MULTILAYER CERAMIC CAPACITORS (XC308, XC251, XC259, AND XC263) FOR CONCERTO II MODEL D274TRK; CONSULTA MODEL D224TRK; AND MAXIMO II MODELD284TRK; MAXIMO II MODELS D284DRG, D2S4VRC; SECURA MODELS D224DRG, D224VRC; ANDVIRTUOSO MODELS D274DRG. D274VRG; ENRHYTHM MODEL P1501DR; VITATRON DA+ C- SERIES MODELS C20A1, C20A3, C60A1, C60A3; AND VITATRON DA+ T-SERIES MODELS T2OA1, T6OA1;