CONSERVE PLUS TOTAL RESURFACING SYSTEM
FDA premarket approval P030042/S004 · decided 2011-08-08
Approval details
- PMA number
- P030042
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CONSERVE PLUS TOTAL RESURFACING SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Microport Orthopedics, Inc.
- Date received
- 2010-08-27
- Decision date
- 2011-08-08
- Days to decision
- 346 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE CONSERVE PLUS A-CLASS FEMORAL COMPONENT AND THE CONSERVE PLUS THICK ACETABULAR SHELL TO BE USED AS COMPONENTS OF THE DEVICE.
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