PMA P150016S017
- Device
- Tridyne Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S017
- Product code
- NBE
- Decision date
- 2019-02-22
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Change to implement multiple autoclaving cycles for carboys that directly contact materials used in the manufacture of approved device.
Current openFDA PMA Record#
- Device
- Tridyne Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S017
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2019-02-22
- Decision code
- OK30
- Date received
- 2019-01-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to implement multiple autoclaving cycles for carboys that directly contact materials used in the manufacture of approved device.