PMA P970010S002

Device
NORIAN SRS CEMENT
Applicant
Synthes (Usa)
PMA number
P970010
Supplement
S002
Product code
LOD
Decision date
2000-04-28
Classification
Bone Cement
Generic name
BONE CEMENT
Approval order statement
Approval of the real time shelf life protocol for purposes of extending the shelf life.

Current openFDA PMA Record#

Device
NORIAN SRS CEMENT
Applicant
Synthes (Usa)
PMA number
P970010
Supplement
S002
Product code
LOD
Generic name
BONE CEMENT
Decision date
2000-04-28
Decision code
APPR
Date received
2000-03-02
Supplement type
Normal 180 Day Track
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the real time shelf life protocol for purposes of extending the shelf life.