PMA P140018S024
- Device
- VenaSeal Closure System
- Applicant
- Medtronic Vascular, Inc.
- Product code
- PJQ
- Decision date
- 2021-06-15
- Generic name
- Agent, occluding, vascular, permanent
- Approval order statement
- Approval for a T=12 and 30 month shelf-life specification for the Stabilizer A component of greater than or equal to 175 ug/g for the VenaSeal Adhesive.
Current openFDA PMA Record#
- Device
- VenaSeal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S024
- Product code
- PJQ
- Generic name
- Agent, occluding, vascular, permanent
- Decision date
- 2021-06-15
- Decision code
- APPR
- Date received
- 2021-03-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a T=12 and 30 month shelf-life specification for the Stabilizer A component of greater than or equal to 175 ug/g for the VenaSeal Adhesive.