PMA P140018S011
- Device
- VenaSeal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S011
- Product code
- PJQ
- Decision date
- 2018-04-24
- Classification
- Agent, Occluding, Vascular, Permanent
- Generic name
- Agent, occluding, vascular, permanent
- Approval order statement
- Implementation of an extension to the allowable time between the sterilization cycle and the sterility testing for the VenaSeal Closure System.
Current openFDA PMA Record#
- Device
- VenaSeal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S011
- Product code
- PJQ
- Generic name
- Agent, occluding, vascular, permanent
- Decision date
- 2018-04-24
- Decision code
- OK30
- Date received
- 2018-03-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an extension to the allowable time between the sterilization cycle and the sterility testing for the VenaSeal Closure System.