Focal Seal-L Synthetic Absorbable Sealant

FDA premarket approval P990028 · Sealant, polymerizing

PMA numberP990028

Approval

Applicant
Genzyme Corp.
Received
June 7, 1999
Decision date
May 26, 2000 (APWD)
Supplements
5, latest December 4, 2003
Product code
NBE – Sealant, Polymerizing

Official FDA PMA record

Approval order statement

APPROVAL FOR THE FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT.