EXCOSEAL VASCULAR CLOSURE DEVICE
FDA premarket approval P100013/S007 · decided 2012-12-13
Approval details
- PMA number
- P100013
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXCOSEAL VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2012-11-13
- Decision date
- 2012-12-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- ALTERNATE STERILIZATION MINIMUM DOSE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.