PMA P150016S013
- Device
- Tridyne Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S013
- Product code
- NBE
- Decision date
- 2018-05-04
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Use of calibrated spray tips ('standards') in the flow rate testing process.
Current openFDA PMA Record#
- Device
- Tridyne Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S013
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2018-05-04
- Decision code
- OK30
- Date received
- 2018-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of calibrated spray tips ('standards') in the flow rate testing process.