PMA P140018S041
- Device
- VENASEAL CLOSURE SYSTEM
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S041
- Product code
- PJQ
- Decision date
- 2024-05-30
- Classification
- Cardiovascular
- Generic name
- Agent, occluding, vascular, permanent
- Approval order statement
- approval for changing the minimum flexural modulus specification for the hub of the introducer, dilator, and catheter
Current openFDA PMA Record#
- Device
- VENASEAL CLOSURE SYSTEM
- Applicant
- Medtronic Vascular, Inc.
- PMA number
- P140018
- Supplement
- S041
- Product code
- PJQ
- Generic name
- Agent, occluding, vascular, permanent
- Decision date
- 2024-05-30
- Decision code
- APPR
- Date received
- 2024-03-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for changing the minimum flexural modulus specification for the hub of the introducer, dilator, and catheter