PMA P990037S036
- Device
- Duett Sealing Device (D-Stat Flowable)
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S036
- Product code
- MGB
- Decision date
- 2022-11-04
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval for minor design and manufacturing changes to the D-Stat Flowable device diluent vial and packaging sealed tray.
Current openFDA PMA Record#
- Device
- Duett Sealing Device (D-Stat Flowable)
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S036
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2022-11-04
- Decision code
- APPR
- Date received
- 2022-08-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for minor design and manufacturing changes to the D-Stat Flowable device diluent vial and packaging sealed tray.