PMA P140018S034
- Device
- VenaSeal ™ Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S034
- Product code
- PJQ
- Decision date
- 2022-09-13
- Generic name
- Agent, occluding, vascular, permanent
- Approval order statement
- Change to the bioburden action and alert limits for the VenaSeal Closure System.
Current openFDA PMA Record#
- Device
- VenaSeal ™ Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S034
- Product code
- PJQ
- Generic name
- Agent, occluding, vascular, permanent
- Decision date
- 2022-09-13
- Decision code
- OK30
- Date received
- 2022-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the bioburden action and alert limits for the VenaSeal Closure System.