|
Device | CAPSURE SP NOVUS & CAPSURE Z NOVUS |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P850089 |
Supplement Number | S057 |
Date Received | 03/10/2008 |
Decision Date | 10/30/2009 |
Product Code |
NVY |
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 | Yes |
Approval Order Statement APPROVAL FOR TRANSFER OF A MANUFACTURING LOCATION FOR A COMPONENT OF THE LEADS. |