PMA P150016S023
- Device
- TRIDYNE™ Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S023
- Product code
- NBE
- Decision date
- 2023-02-07
- Classification
- Cardiovascular
- Generic name
- Sealant, polymerizing
- Approval order statement
- Change water quality inspection method from Oxidized Substances test to Total Organic Carbon test.
Current openFDA PMA Record#
- Device
- TRIDYNE™ Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S023
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2023-02-07
- Decision code
- OK30
- Date received
- 2023-01-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change water quality inspection method from Oxidized Substances test to Total Organic Carbon test.