PMA P990028S006
- Device
- FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
- Applicant
- Genzyme Corp.
- PMA number
- P990028
- Supplement
- S006
- Product code
- FTL
- Decision date
- 2003-02-04
- Generic name
- Mesh, surgical, polymeric
- Approval order statement
- APPROVAL FOR REVISION OF STORAGE INSTRUCTIONS IN THE PRODUCT LABEL.
Current openFDA PMA Record#
- Device
- FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
- Applicant
- Genzyme Corp.
- PMA number
- P990028
- Supplement
- S006
- Product code
- FTL
- Generic name
- Mesh, surgical, polymeric
- Decision date
- 2003-02-04
- Decision code
- APPR
- Date received
- 2003-01-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISION OF STORAGE INSTRUCTIONS IN THE PRODUCT LABEL.