EXOSEAL Vascular Closure Device
FDA premarket approval P100013/S014 · decided 2017-08-07
Approval details
- PMA number
- P100013
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXOSEAL Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2017-04-11
- Decision date
- 2017-08-07
- Days to decision
- 118 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for the addition of Cordis Corporation, Miami Lakes, Florida as an alternate supplier for the Delivery Shaft component of the 6F EXOSEAL Vascular Closure Device.
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