PMA P970010S001

Device
NORIAN SRS CEMENT
Applicant
Synthes (Usa)
PMA number
P970010
Supplement
S001
Product code
LOD
Decision date
1999-07-16
Generic name
BONE CEMENT
Approval order statement
Approval for the post-approval clinical and animal study protocols that were requested as Conditions of Approval for the PMA.

Current openFDA PMA Record#

Device
NORIAN SRS CEMENT
Applicant
Synthes (Usa)
PMA number
P970010
Supplement
S001
Product code
LOD
Generic name
BONE CEMENT
Decision date
1999-07-16
Decision code
APPR
Date received
1999-02-08
Supplement type
Normal 180 Day Track
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval for the post-approval clinical and animal study protocols that were requested as Conditions of Approval for the PMA.