PMA P960001S004

Device: DEPUY 3 BONE CEMENT
Applicant: Depuy, Inc.
PMA number: P960001
Supplement: S004
Product code: LOD
Decision date: 1999-07-13
Generic name: BONE CEMENT
Approval order statement: Approval for a new bone cement formulation, in order to change the cement's handling characteristics. The device is indicated for the fixation of prostheses to living bone in Orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Current openFDA PMA Record

Device: DEPUY 3 BONE CEMENT
Applicant: Depuy, Inc.
PMA number: P960001
Supplement: S004
Product code: LOD
Generic name: BONE CEMENT
Decision date: 1999-07-13
Decision code: APPR
Date received: 1998-06-15
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a new bone cement formulation, in order to change the cement's handling characteristics. The device is indicated for the fixation of prostheses to living bone in Orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.