- Device
- VenaSeal™ Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S033
- Product code
- PJQ
- Generic name
- Agent, occluding, vascular, permanent
- Decision date
- 2023-04-03
- Decision code
- APPR
- Date received
- 2022-07-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the biological indicator used during the sterilization of the VenaSeal adhesive at the Medtronic Galway facility.