|
Device | MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD |
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 | P830061 |
Supplement Number | S025 |
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 THE USE OF 12 PERCENT ETHYLENE OXIDE (ET0), 88 PERCENT CFC, TO 100 PERCENT ETO |