VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES

FDA premarket approval P990001/S080 · decided 2011-03-22

Approval details

PMA number

P990001

Supplement

S080

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

VITATRON DA + C-SERIESAND VITATRON DA + T-SERIES

Generic name

Pulse generator, permanent, implantable

Applicant

Medtronic, Inc.

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;

510(k) clearances by this applicant