Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | LEGOO |
Generic Name | Occluder, internal vessel, temporary |
Applicant | GENZYME CORP. 52 Binney Street Cambridge, MA 02142 |
PMA Number | P110003 |
Date Received | 01/31/2011 |
Decision Date | 09/28/2011 |
Withdrawal Date
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05/21/2024 |
Product Code |
OBC |
Docket Number | 11M-0746 |
Notice Date | 10/20/2011 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00985634
|
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE LEGOO. THIS DEVICE IS INDICATED FOR TEMPORARY ENDOVASCULAR OCCLUSION OF BLOOD VESSELS BELOW THE NECK UP TO 4 MM IN DIAMETER. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S004 S002 S001 S003 |
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