|
Device | CAPSURE(R) AND CAPSURE(R)SP LEADS |
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 | S032 |
Date Received | 01/30/1995 |
Decision Date | 10/31/1995 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE STERILIZATION PROCESS FROM HTE USE OF 12 PERCENT ETHYLENE OXIDE (ET0), 88 PERCENT CFC, TO 100 PERCENT ET0 |