PMA P150016S025
- Device
- TRIDYNE™ Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S025
- Product code
- NBE
- Decision date
- 2025-05-09
- Classification
- Cardiovascular
- Generic name
- Sealant, polymerizing
- Approval order statement
- reinstatement of quarterly dose auditing for the chemistry kit component of the PROGEL and TRIDYNE sealant products
Current openFDA PMA Record#
- Device
- TRIDYNE™ Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S025
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2025-05-09
- Decision code
- OK30
- Date received
- 2025-04-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reinstatement of quarterly dose auditing for the chemistry kit component of the PROGEL and TRIDYNE sealant products