- Device
- DUETT PROSEALING DEVICE (MODEL 1010), DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210), AND D-STAT FLOWABLE HEMOSTAT...
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S023
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2005-09-02
- Decision code
- APPR
- Date received
- 2005-08-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO MODIFY THE PROCEDURE FOR DETERMINING ACCEPTANCE OF THE LIMULUS AMEBOCYTE LEVEL (LAL) TEST RESULTS.