Closer Vascular Sealing System (VSS)
FDA premarket approval P150022/S005 · decided 2018-07-10
Approval details
- PMA number
- P150022
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Closer Vascular Sealing System (VSS)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Rex Medical, L.P.
- Date received
- 2018-05-21
- Decision date
- 2018-07-10
- Days to decision
- 50 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Conshohocken, PA
- Statement
- Approval for a change to the maximum tightening force exerted by the delivery system during device deployment.
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