PMA N18466S020

Device: CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.
Applicant: Depuy, Inc.
PMA number: N18466
Supplement: S020
Product code: LOD
Decision date: 1995-11-20
Generic name: BONE CEMENT
Approval order statement: APPROVAL FOR THE FOLLOWING:1)ADDITION OF A DISTRIBUTOR LABEL TO BE PLACED ON TO THE BOTTOM OF THE OUTER CARTON; AND 2) THE STERILE POWDER PACKAGE WILL BE PLACED INTO A NONSTERILE PROTECTIVE LAMINATED FOIL POUCH

Current openFDA PMA Record

Device: CMW BONE CEMENT, CMW 1, CMW 1 RADIOPAQUE, CMW 2, AND CMW 3 BONE CEMENTS.
Applicant: Depuy, Inc.
PMA number: N18466
Supplement: S020
Product code: LOD
Generic name: BONE CEMENT
Decision date: 1995-11-20
Decision code: APPR
Date received: 1995-09-28
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE FOLLOWING:1)ADDITION OF A DISTRIBUTOR LABEL TO BE PLACED ON TO THE BOTTOM OF THE OUTER CARTON; AND 2) THE STERILE POWDER PACKAGE WILL BE PLACED INTO A NONSTERILE PROTECTIVE LAMINATED FOIL POUCH