Cordis® EXOSEAL® Vascular Closure Device
FDA premarket approval P100013/S028 · decided 2023-10-31
Approval details
- PMA number
- P100013
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cordis® EXOSEAL® Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2023-10-03
- Decision date
- 2023-10-31
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- to implement new suppliers for molded components of the Cordis EXOSEAL Vascular Closure Device
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