PMA P050050S005

Device: SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)
Applicant: Djo Global
PMA number: P050050
Supplement: S005
Product code: NTG
Decision date: 2013-01-24
Classification: Prosthesis, Ankle, Uncemented, Non-constrained
Generic name: Prosthesis, ankle, uncemented, non-constrained
Approval order statement: APPROVAL FOR A REVISED PACKAGE INSERT WHICH INCLUDES ADDITIONAL POTENTIAL ADVERSE EVENTS REPORTED IN RECENT STAR ANKLE PUBLICATIONS.

Current openFDA PMA Record#

Device: SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)
Applicant: Djo Global
PMA number: P050050
Supplement: S005
Product code: NTG
Generic name: Prosthesis, ankle, uncemented, non-constrained
Decision date: 2013-01-24
Decision code: APPR
Date received: 2012-11-13
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A REVISED PACKAGE INSERT WHICH INCLUDES ADDITIONAL POTENTIAL ADVERSE EVENTS REPORTED IN RECENT STAR ANKLE PUBLICATIONS.