|
Device | ATTAIN LEAD |
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 | S111 |
Date Received | 03/18/2011 |
Decision Date | 06/16/2011 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY. |
Post-Approval Study | Show Report Schedule and Study Progress |