EXOSEAL VASCULAR CLOSURE DEVICE
FDA premarket approval P100013/S001 · decided 2011-08-25
Approval details
- PMA number
- P100013
- Supplement
- S001
- Supplement type
- 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
- 2011-07-28
- Decision date
- 2011-08-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- CHANGE IN THE PROCESSING OF A COMPONENT OF THE DEVICE.
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