PMA P150016S011
- Device
- Tridyne Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S011
- Product code
- NBE
- Decision date
- 2018-02-05
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Expand the use of the Lighthouse Monitoring System (LMS) to additional cleanroom and product storage areas.
Current openFDA PMA Record#
- Device
- Tridyne Vascular Sealant
- Applicant
- Neomend, Inc.
- PMA number
- P150016
- Supplement
- S011
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2018-02-05
- Decision code
- OK30
- Date received
- 2018-01-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Expand the use of the Lighthouse Monitoring System (LMS) to additional cleanroom and product storage areas.