|
Device | ATTAIN ABILITY |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432 |
PMA Number | P080006 |
Supplement Number | S041 |
Date Received | 06/11/2012 |
Decision Date | 07/11/2012 |
Product Code |
OJX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement UPDATE THE DRUG COMPONENT AND FINISHED LEAD SPECIFICATION OF THE ATTAIN ABILITY FAMILY OF LEADS AND THE ADDITION OF AN ALTERNATE TESTING LABORATORY AN ALTERNATE ANALYTICAL METHODS. |