PMA P970010S004

Device
NORIAN SRS BONE CEMENT
Applicant
Synthes (Usa)
PMA number
P970010
Supplement
S004
Product code
LOD
Decision date
2000-08-31
Classification
Bone Cement
Generic name
BONE CEMENT
Approval order statement
APPROVAL FOR CHANGING THE VOLUME OF MATERIAL USED IN THE POST-APPROVAL RABBIT STUDY.

Current openFDA PMA Record#

Device
NORIAN SRS BONE CEMENT
Applicant
Synthes (Usa)
PMA number
P970010
Supplement
S004
Product code
LOD
Generic name
BONE CEMENT
Decision date
2000-08-31
Decision code
APPR
Date received
2000-06-06
Supplement type
Normal 180 Day Track
Supplement reason
Postapproval Study Protocol
Approval order statement
APPROVAL FOR CHANGING THE VOLUME OF MATERIAL USED IN THE POST-APPROVAL RABBIT STUDY.