CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM
FDA premarket approval P030042/S002 · decided 2010-07-16
Approval details
- PMA number
- P030042
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Microport Orthopedics, Inc.
- Date received
- 2010-01-21
- Decision date
- 2010-07-16
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.