PMA P040051

Device
STELKAST SURPASS ACETABULAR SYSTEM
Applicant
Stelkast Company
PMA number
P040051
Supplement
S002
Product code
MRA
Decision date
2011-04-22
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
STELKAST SURPASS ACETABULAR SYSTEM
Applicant
Stelkast Company
PMA number
P040051
Supplement
S002
Product code
MRA
Generic name
Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Decision date
2011-04-22
Decision code
APPR
Date received
2009-10-06
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.