PMA N12159

Device
SURGICELTM POWDER Absorbable Hemostatic Powder
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S096
Product code
LMG
Decision date
2026-07-28
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
for the use of a New Resin and Mold at Alltrista Plastics, an Ethicon, Inc. External Supplier

Current openFDA PMA Record#

Device
SURGICELTM POWDER Absorbable Hemostatic Powder
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S129
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2026-07-28
Decision code
APPR
Date received
2026-03-06
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
for the use of a New Resin and Mold at Alltrista Plastics, an Ethicon, Inc. External Supplier