PMA P150016S001
- Device
- TRIDYNE VASCULAR SEALANT
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S001
- Product code
- NBE
- Decision date
- 2016-07-27
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Expansion of the cleanrooms used in the manufacture of Tridyne Vascular Sealant at the existing location, 60 Technology Drive, Irvine, California.
Current openFDA PMA Record#
- Device
- TRIDYNE VASCULAR SEALANT
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S001
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2016-07-27
- Decision code
- OK30
- Date received
- 2016-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expansion of the cleanrooms used in the manufacture of Tridyne Vascular Sealant at the existing location, 60 Technology Drive, Irvine, California.