FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT

FDA Premarket Approval P990028 S006

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

Approval for revision of storage instructions in the product label.

DeviceFOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
Generic NameMesh, Surgical, Polymeric
ApplicantGENZYME CORP.
Date Received2003-01-15
Decision Date2003-02-04
PMAP990028
SupplementS006
Product CodeFTL 
Advisory CommitteeAnesthesiology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address GENZYME CORP. 55 Cambridge Parkway cambridge, MA 02142

Supplemental Filings

Supplement NumberDateSupplement Type
P990028Original Filing
S007 2003-11-12 Normal 180 Day Track No User Fee
S006 2003-01-15 Special (immediate Track)
S005 2002-10-17 Special (immediate Track)
S004
S003
S002 2001-01-09 Real-time Process
S001 2000-07-28 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.