PMA P960001S001

Device: ENDURANCE BONE CEMENT
Applicant: Depuy, Inc.
PMA number: P960001
Supplement: S001
Product code: LOD
Decision date: 1997-11-12
Generic name: BONE CEMENT
Approval order statement: Approval for new PMMA/MMA-Styrene co-polymer formulation. The device, as modified, will be marketed under the trade Endurace Bone Cement and is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal srugical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other condtions and revision of previous arthroplasty.

Current openFDA PMA Record

Device: ENDURANCE BONE CEMENT
Applicant: Depuy, Inc.
PMA number: P960001
Supplement: S001
Product code: LOD
Generic name: BONE CEMENT
Decision date: 1997-11-12
Decision code: APPR
Date received: 1997-02-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for new PMMA/MMA-Styrene co-polymer formulation. The device, as modified, will be marketed under the trade Endurace Bone Cement and is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal srugical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other condtions and revision of previous arthroplasty.