|
Device | CAPSUREFIX NOVUS LEAD, SUREFIX LEAD |
Generic Name | Permanent defibrillator electrodes |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P930039 |
Supplement Number | S033 |
Date Received | 10/08/2009 |
Decision Date | 01/21/2010 |
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 REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES. |