PMA P990028S001
- Device
- FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT
- Applicant
- Genzyme Corp.
- PMA number
- P990028
- Supplement
- S001
- Product code
- FTL
- Decision date
- 2001-04-20
- Generic name
- Mesh, surgical, polymeric
- Approval order statement
- APPROVAL FOR THE POST APPROVAL STUDY PROTOCOL PMS-0001-0.
Current openFDA PMA Record#
- Device
- FOCALSEAL-L SYNTHETIC ABLSORBABLE SEALANT
- Applicant
- Genzyme Corp.
- PMA number
- P990028
- Supplement
- S001
- Product code
- FTL
- Generic name
- Mesh, surgical, polymeric
- Decision date
- 2001-04-20
- Decision code
- APPR
- Date received
- 2000-07-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR THE POST APPROVAL STUDY PROTOCOL PMS-0001-0.