PMA P150016S008
- Device
- Tridyne Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S008
- Product code
- NBE
- Decision date
- 2018-01-02
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Changes to the manufacturing of the extended applicator tip, assembly/sealing/packaging, labeling processes, and environmental controls of TRIDYNE Vascular Sealant.
Current openFDA PMA Record#
- Device
- Tridyne Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S008
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2018-01-02
- Decision code
- OK30
- Date received
- 2017-11-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the manufacturing of the extended applicator tip, assembly/sealing/packaging, labeling processes, and environmental controls of TRIDYNE Vascular Sealant.