|
Device | SELECTSECURE LEAD |
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 | S051 |
Date Received | 10/26/2012 |
Decision Date | 12/19/2012 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR CHANGE IN SILICONE TUBING MATERIAL USED IN THE MANUFACTURE OF VARIOUS CARDIAC LEADS AS A RESULT OF DISCONTINUATION OF THE CURRENT MATERIAL BY AN OUTSIDE SUPPLIER. |