|
Device | ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD, 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 | S197 |
Date Received | 04/10/2013 |
Decision Date | 12/24/2013 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE. |
Post-Approval Study | Show Report Schedule and Study Progress |