PMA P210036

Device
PerClot® Polysaccharide Hemostatic System
Applicant
Baxter Healthcare Corporation
Product code
LMG
Decision date
2025-04-25
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
redesign to the PerClot 38cm Laparoscopic Tip

Current openFDA PMA Record#

Device
PerClot® Polysaccharide Hemostatic System
Applicant
Baxter Healthcare Corporation
PMA number
P210036
Supplement
S005
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2025-04-25
Decision code
APPR
Date received
2025-01-27
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
redesign to the PerClot 38cm Laparoscopic Tip