PMA P150016S002
- Device
- TRIDYNE VASCULAR SEALANT, TRIDYNE EXTENDED APPLICATOR SPRAY TIP.
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S002
- Product code
- NBE
- Decision date
- 2016-12-19
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Addition of alternate suppliers of testing services and reagents for quality testing of the Tridyne Vascular Sealant.
Current openFDA PMA Record#
- Device
- TRIDYNE VASCULAR SEALANT, TRIDYNE EXTENDED APPLICATOR SPRAY TIP.
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S002
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2016-12-19
- Decision code
- OK30
- Date received
- 2016-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternate suppliers of testing services and reagents for quality testing of the Tridyne Vascular Sealant.