PMA N17004

Device
SURGICAL SIMPLEX P BONE CEMENT
Applicant
Howmedica Corp.
PMA number
N17004
Supplement
S013
Product code
LOD
Decision date
2000-12-15
Classification
Bone Cement
Generic name
BONE CEMENT
Approval order statement
APPROVAL FOR REMOVAL OF THE REDUNDANT CHEMICAL NAME LOCATED DIRECTLY BELOW THE BRAND NAME.

Current openFDA PMA Record#

Device
SURGICAL SIMPLEX P BONE CEMENT
Applicant
Howmedica Corp.
PMA number
N17004
Supplement
S013
Product code
LOD
Generic name
BONE CEMENT
Decision date
2000-12-15
Decision code
APPR
Date received
2000-12-01
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR REMOVAL OF THE REDUNDANT CHEMICAL NAME LOCATED DIRECTLY BELOW THE BRAND NAME.