PMA P150016S006
- Device
- TRIDYNE Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S006
- Product code
- NBE
- Decision date
- 2017-11-29
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Manufacturing process and location change of DuPont’s production of Tyvek used in the manufacture of packaging material for the device.
Current openFDA PMA Record#
- Device
- TRIDYNE Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S006
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2017-11-29
- Decision code
- OK30
- Date received
- 2017-10-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process and location change of DuPont’s production of Tyvek used in the manufacture of packaging material for the device.