PMA P990037S034
- Device
- D-Stat Flowable hemostat
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S034
- Product code
- MGB
- Decision date
- 2016-10-05
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Implement renovations to controlled environmental areas within the same facility.
Current openFDA PMA Record#
- Device
- D-Stat Flowable hemostat
- Applicant
- Vascular Solutions, Inc.
- PMA number
- P990037
- Supplement
- S034
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2016-10-05
- Decision code
- OK30
- Date received
- 2016-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement renovations to controlled environmental areas within the same facility.