|
Device | ATTAIN/CONSULTA CRT-P/SYNCRA CRT-P |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S148 |
Date Received | 11/21/2011 |
Decision Date | 02/28/2013 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 080118 MEDICAL ADHESIVE USED AS AN ACCESSORY FOR THE ATTAIN, CONSULTA, AND SYNCRA CRT-PS. |