PMA P990037S035
- Device
- Duett Sealing Device
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S035
- Product code
- MGB
- Decision date
- 2021-07-13
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Alternate sealer for the sterile barrier of the D-Stat Flowable Hemostat of the Duett Sealing Device.
Current openFDA PMA Record#
- Device
- Duett Sealing Device
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S035
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2021-07-13
- Decision code
- OK30
- Date received
- 2021-06-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate sealer for the sterile barrier of the D-Stat Flowable Hemostat of the Duett Sealing Device.