PMA P140018S019
- Device
- VenaSeal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S019
- Product code
- PJQ
- Decision date
- 2020-04-10
- Generic name
- Agent, occluding, vascular, permanent
- Approval order statement
- Approval for a change to the Instructions for Use for the VenaSeal Closure System that further defines the exiting steps.
Current openFDA PMA Record#
- Device
- VenaSeal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S019
- Product code
- PJQ
- Generic name
- Agent, occluding, vascular, permanent
- Decision date
- 2020-04-10
- Decision code
- APPR
- Date received
- 2020-03-10
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change to the Instructions for Use for the VenaSeal Closure System that further defines the exiting steps.