|
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 | S063 |
Date Received | 09/26/2013 |
Decision Date | 10/25/2013 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MINOR CHANGES TO THE PLASMA TREATMENT PROCESS FOR A SILICONE TUBING COMPONENT USED IN THE MODEL 3830 SELECTSECURE LEAD. |