|
Device | LEGOO ENDOVASCULAR OCCLUDER |
Generic Name | Occluder, internal vessel, temporary |
Applicant | GENZYME CORP. 52 Binney Street Cambridge, MA 02142 |
PMA Number | P110003 |
Supplement Number | S001 |
Date Received | 11/15/2011 |
Decision Date | 03/01/2012 |
Product Code |
OBC |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO A STERILIZATION PROCESS PARAMETER. |