PMA N12159S068

Device
Surgicel Powder Absorbable Hemostatic Powder
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S068
Product code
LMG
Decision date
2020-03-04
Generic name
Agent, absorbable hemostatic, non-collagen based
Approval order statement
Relocation of the existing secondary packaging equipment within the existing facility.

Current openFDA PMA Record#

Device
Surgicel Powder Absorbable Hemostatic Powder
Applicant
ETHICON, Inc.
PMA number
N12159
Supplement
S068
Product code
LMG
Generic name
Agent, absorbable hemostatic, non-collagen based
Decision date
2020-03-04
Decision code
OK30
Date received
2020-02-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Relocation of the existing secondary packaging equipment within the existing facility.