|
Device | MEDTRONIC CAPSURE(R) SP MODEL 5024M/5524M PACING 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 | S035 |
Date Received | 05/08/1996 |
Decision Date | 03/07/1997 |
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 THE USE OF NUSIL MED-4719 AS AN ALTERNATE SILICONE INSULATOR FOR MDX4-4516 |