PMA P140018S046
- Device
- VenaSeal™ Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S046
- Product code
- PJQ
- Decision date
- 2025-09-23
- Classification
- Cardiovascular
- Generic name
- Agent, occluding, vascular, permanent
- Approval order statement
- a change to the adhesive coating on the Tyvek lid used to form the sterile barrier of the VenaSeal Closure System
Current openFDA PMA Record#
- Device
- VenaSeal™ Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S046
- Product code
- PJQ
- Generic name
- Agent, occluding, vascular, permanent
- Decision date
- 2025-09-23
- Decision code
- OK30
- Date received
- 2025-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the adhesive coating on the Tyvek lid used to form the sterile barrier of the VenaSeal Closure System