|
Device | CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SUREFIX LEAD, VITATRON CRYSTALLINE LEAD |
Generic Name | Permanent defibrillator electrodes |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P930039 |
Supplement Number | S085 |
Date Received | 04/09/2013 |
Decision Date | 12/24/2013 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE. |