|
Device | INSYNC III CRT-P/ATTAIN OTW LEAD/BIPOLAR OTW/LV LEADS |
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 | S112 |
Date Received | 03/22/2011 |
Decision Date | 06/27/2011 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CHANGE OF THE CLEANING CONTROL AREA AND THE ASSOCIATED PROCESSES. |