EXOSEAL VASCULAR CLOSURE DEVICE
FDA premarket approval P100013/S003 · decided 2012-09-19
Approval details
- PMA number
- P100013
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EXOSEAL VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2011-12-12
- Decision date
- 2012-09-19
- Days to decision
- 282 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR THE PATIENT BROCHURE.
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