EXOSEAL Vascular Closure Device
FDA premarket approval P100013/S027 · decided 2023-12-23
Approval details
- PMA number
- P100013
- Supplement
- S027
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXOSEAL Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2023-06-14
- Decision date
- 2023-12-23
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- approval for a manufacturing site located at Steri-Tek, Lewisville, Texas as a new sterilization site.
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