CONCERTO II, CONSULTA AND MAXIMO II

FDA premarket approval P010031/S222 · decided 2011-03-22

Approval details

PMA number

P010031

Supplement

S222

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CONCERTO II, CONSULTA AND MAXIMO II

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic Cardiac Rhythm Disease Management

Date received

2010-12-07

Decision date

2011-03-22

Days to decision

105 days

Decision code

APPR

Product code

NVZ

Advisory committee

Cardiovascular

Expedited review

No

Location

Mounds View, MN

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;