|
Device | Masters Mechanical Heart Valve |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S113 |
Date Received | 07/23/2021 |
Decision Date | 08/19/2021 |
Product Code |
LWQ |
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 labeling changes specific for each valve configuration in a precaution statement in the Instructions for Use. |