Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | MASTERS SERIES COATED AORTIC VALVED GRAFT(MODEL CAVGJ-514) |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S049 |
Date Received | 02/09/1999 |
Decision Date | 07/28/1999 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the SJM(R) Master Series Aortic Valved Graft with Meadox(R) Hemashield(R) Woven Double Velour Graft, Model CAVGJ-514, in sizes 19, 21, 23, 25, 27, 29, 31, and 33 mm. This device is indicated for use when the aortic valve and the ascending aorta must be replaced. |
|
|