DUETT PROSEALING DEVICE (MODEL 1010), DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210), AND D-STAT FLOWABLE HEMOSTAT...
FDA premarket approval P990037/S023 · decided 2005-09-02
Approval details
- PMA number
- P990037
- Supplement
- S023
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DUETT PROSEALING DEVICE (MODEL 1010), DIAGNOSTIC DUETT PRO SEALING DEVICE (MODEL 2210), AND D-STAT FLOWABLE HEMOSTAT...
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2005-08-05
- Decision date
- 2005-09-02
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL TO MODIFY THE PROCEDURE FOR DETERMINING ACCEPTANCE OF THE LIMULUS AMEBOCYTE LEVEL (LAL) TEST RESULTS.
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