CONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL

FDA Premarket Approval P030042 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the post-approval study protocol.

DeviceCONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL
Generic NameProsthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
ApplicantMicroPort Orthopedics Inc.
Date Received2010-01-21
Decision Date2010-06-21
PMAP030042
SupplementS003
Product CodeNXT 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Osb
Expedited ReviewNo
Combination Product No
Applicant Address MicroPort Orthopedics Inc. 5677 Airline Rd arlington, TN 38002

Supplemental Filings

Supplement NumberDateSupplement Type
P030042Original Filing
S004 2010-08-27 Real-time Process
S003 2010-01-21 Normal 180 Day Track No User Fee
S002 2010-01-21 Normal 180 Day Track No User Fee
S001

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