LEGOO

FDA Premarket Approval P110003 S004

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.

Pre-market Approval Supplement Details

Implementation of a modified legoo filling and inspection process for the 1. 0 ml and 2. 5 ml legoo syringes.

DeviceLEGOO
Generic NameOccluder, Internal Vessel, Temporary
ApplicantGENZYME CORP.
Date Received2014-02-27
Decision Date2014-03-26
PMAP110003
SupplementS004
Product CodeOBC 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address GENZYME CORP. 52 Binney Street cambridge, MA 02142

Supplemental Filings

Supplement NumberDateSupplement Type
P110003Original Filing
S004 2014-02-27 30-day Notice
S003 2012-10-19 30-day Notice
S002 2012-10-15 30-day Notice
S001 2011-11-15 135 Review Track For 30-day Notice

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