|
Device | CAPSURE SP MODEL 5024M AND SUREFIX MODEL 5072 LEADSRIES |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P850089 |
Supplement Number | S050 |
Date Received | 11/14/2001 |
Decision Date | 12/19/2001 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FOLLOWING: 1) A CHANGE IN OUTER INSULATION TREATMENT FROM SILACURE TO SILOXANE FOR THE CAPSURE SP MODEL 5024M LEAD; 2) A MATERIAL CHANGE FROM MDX SILICONE TO MED 4719 SILICONE FOR SUREFIX MODEL 5072 INNER AND OUTER INSULATION (OUTER INSULATION WITH SILOXANE TREATMENT); AND 3) ASSOCIATED MINOR LABELING CHANGES. |