|
Device | HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT |
Generic Name | heart-valve, non-allograft tissue |
Applicant | MEDTRONIC HEART VALVES 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P790007 |
Supplement Number | S040 |
Date Received | 10/25/2013 |
Decision Date | 11/14/2013 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A DESIGN CHANGE TO THE RUBBER GASKET FOR THE JAR USED TO PACKAGE THE DEVICE. |