PMA P150016S012
- Device
- TRIDYNE Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S012
- Product code
- NBE
- Decision date
- 2018-04-20
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Approval for updates to the performance specifications for Tridyne Vascular Sealant.
Current openFDA PMA Record#
- Device
- TRIDYNE Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S012
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2018-04-20
- Decision code
- APPR
- Date received
- 2018-01-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the performance specifications for Tridyne Vascular Sealant.