VENASEAL CLOSURE SYSTEM
FDA premarket approval P140018/S001 · decided 2015-10-07
Approval details
- PMA number
- P140018
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENASEAL CLOSURE SYSTEM
- Generic name
- Agent, occluding, vascular, permanent
- Applicant
- Medtronic Vascular, Inc.
- Date received
- 2015-07-28
- Decision date
- 2015-10-07
- Days to decision
- 71 days
- Decision code
- APPR
- Product code
- PJQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE USE OF A SINGLE STERILE BARRIER PACKAGING SYSTEM FOR THE VENASEAL CLOSURE SYSTEM, IN PLACE OF THE DOUBLE STERILE BARRIER SYSTEM
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