CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM
FDA premarket approval P030042 · decided 2009-11-03
Approval details
- PMA number
- P030042
- Trade name
- CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Microport Orthopedics, Inc.
- Date received
- 2003-09-30
- Decision date
- 2009-11-03
- Days to decision
- 2226 days
- Decision code
- APWD
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- Yes
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THECONSERVE PLUS TOTAL RESURFACING HIP SYSTEM.THE CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS A SINGLE USE DEVICE INTENDED FOR HYBRID FIXATION UTILIZING CEMENTED FEMORAL HEAD COMPONENT AND CEMENTLESS ACETABULAR COMPONENT. THECONSERVE PLUS TOTAL RESURFACING HIP SYSTEM IS INTENDED FOR USE IN RESURFACING HIPARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATUREPATIENTS HAVING THE FOLLOWING CONDITIONS:1) NON-INFLAMMATORY ARTHRITIS (DEGENERATIVE
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