|
Device | CAPSURE FIX LEAD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S221 |
Date Received | 01/15/2010 |
Decision Date | 03/16/2010 |
Product Code |
LWS |
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. |