|
Device | SELECTSECURE 3830 |
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 | S003 |
Date Received | 02/26/2007 |
Decision Date | 10/21/2008 |
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 | Yes |
Approval Order Statement APPROVAL FOR A CHANGE TO THE 1 CC SYRINGE USED TO MANUALLY MEASURE APPLICATION WITH A MANUALLY OPERATED AUTOMATED DISPENSER AND TO MODIFY THE DIMENSIONS OF THE FILLING TUBE TO PREVENT OVER-FILL OF THE PRECISELY MEASURED STEROID SOLUTION WITHIN THE FILLING TUBE. |