PMA P150016S014
- Device
- Tridyne Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S014
- Product code
- NBE
- Decision date
- 2018-06-13
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- New supplier of the Self Contained Biological Indicator (SCBI) used to monitor sterilization of the Tridyne Vascular Sealant.
Current openFDA PMA Record#
- Device
- Tridyne Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S014
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2018-06-13
- Decision code
- OK30
- Date received
- 2018-05-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New supplier of the Self Contained Biological Indicator (SCBI) used to monitor sterilization of the Tridyne Vascular Sealant.