PMA P140018S037
- Device
- VenaSeal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S037
- Product code
- PJQ
- Decision date
- 2023-07-25
- Classification
- Cardiovascular
- Generic name
- Agent, occluding, vascular, permanent
- Approval order statement
- Approval for removing the guidewire included in the VenaSeal Closure system and instructing physicians to source a compatible guidewire for the procedure.
Current openFDA PMA Record#
- Device
- VenaSeal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S037
- Product code
- PJQ
- Generic name
- Agent, occluding, vascular, permanent
- Decision date
- 2023-07-25
- Decision code
- APPR
- Date received
- 2023-05-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for removing the guidewire included in the VenaSeal Closure system and instructing physicians to source a compatible guidewire for the procedure.