|
Device | CAPSURE SP NOVUS Z NOVUS |
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 | S053 |
Date Received | 03/01/2004 |
Decision Date | 06/08/2004 |
Product Code |
DTB |
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 | No |
Approval Order Statement APPROVAL TO MARKET THESE LEAD MODELS MANUFACTURED USING MED 2000 SILICONE ADHESIVE. |