FDA.reportPublic FDA data

PMA N12159S069

Device
SURGICEL Powder Absorbable Hemostatic Powder
Applicant
ETHICON, Inc.
Product code
LMG
Decision date
2020-09-21
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
Approval for a second SURGICEL Powder manufacturing area referred to as Suite 2 in the existing Controlled Manufacturing Environment space at the Ethicon LLC, San Lorenzo, Puerto Rico facility.

Current openFDA PMA Record#

Device
SURGICEL Powder Absorbable Hemostatic Powder
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S069
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2020-09-21
Decision code
APPR
Date received
2020-02-25
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a second SURGICEL Powder manufacturing area referred to as Suite 2 in the existing Controlled Manufacturing Environment space at the Ethicon LLC, San Lorenzo, Puerto Rico facility.