PMA P140018S014
- Device
- Venaseal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S014
- Product code
- PJQ
- Decision date
- 2018-12-07
- Classification
- Agent, Occluding, Vascular, Permanent
- Generic name
- Agent, occluding, vascular, permanent
- Approval order statement
- Implementation of an air leak test to detect leaks in the introducer component of the VenaSeal closure system.
Current openFDA PMA Record#
- Device
- Venaseal Closure System
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S014
- Product code
- PJQ
- Generic name
- Agent, occluding, vascular, permanent
- Decision date
- 2018-12-07
- Decision code
- OK30
- Date received
- 2018-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an air leak test to detect leaks in the introducer component of the VenaSeal closure system.