Legoo
FDA premarket approval P110003 · Occluder, internal vessel, temporary
PMA numberP110003
Approval
- Applicant
- Genzyme Corp.
- Received
- January 31, 2011
- Decision date
- September 28, 2011 (APWD)
- Supplements
- 4, latest March 26, 2014
- Product code
- OBC – Occluder, Internal Vessel, Temporary
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.