PMA P990037S032
- Device
- D-STAT FLOWABLE HEMOSTAT
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S032
- Product code
- MGB
- Decision date
- 2016-02-25
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval for labeling changes to the D-Stat Flowable Hemostat Instructions for Use.
Current openFDA PMA Record#
- Device
- D-STAT FLOWABLE HEMOSTAT
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S032
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2016-02-25
- Decision code
- APPR
- Date received
- 2016-01-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling changes to the D-Stat Flowable Hemostat Instructions for Use.