|
Device | SELECTSECURE LEAD/SLEEVE KIT |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P030036 |
Supplement Number | S027 |
Date Received | 03/22/2011 |
Decision Date | 06/27/2011 |
Product Code |
NVY |
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. |