|
Device | MOSIAC PORCINE BIOPROSTHESIS |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P990064 |
Supplement Number | S053 |
Date Received | 01/09/2014 |
Decision Date | 02/05/2014 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE INCLUSION OF AN INDEXED EFFECTIVE ORIFICE AREA (IEOA) SIZING CHART IN THE IFU AND AN UPDATE TO THE SIZERS TO ALIGN WITH THE UPDATED IEOA SIZING CHART. |