PMA P990028S005
- Device
- FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
- Applicant
- Genzyme Corp.
- PMA number
- P990028
- Supplement
- S005
- Product code
- FTL
- Decision date
- 2002-11-25
- Generic name
- Mesh, surgical, polymeric
- Approval order statement
- APPROVAL FOR THE ADDITION OF A BOX AROUND THE CONTRAINDICATIONS SECTION OF THE INSTRUCTIONS FOR USE FOR FOCALSEAL-L SEALANT.
Current openFDA PMA Record#
- Device
- FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT
- Applicant
- Genzyme Corp.
- PMA number
- P990028
- Supplement
- S005
- Product code
- FTL
- Generic name
- Mesh, surgical, polymeric
- Decision date
- 2002-11-25
- Decision code
- APPR
- Date received
- 2002-10-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF A BOX AROUND THE CONTRAINDICATIONS SECTION OF THE INSTRUCTIONS FOR USE FOR FOCALSEAL-L SEALANT.