SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT

Bone Cement

FDA Premarket Approval N17004 S006

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

DeviceSURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT
Classification NameBone Cement
Generic NameBone Cement
ApplicantHOWMEDICA CORP.
Date Received1994-09-26
Decision Date1995-02-24
PMAN17004
SupplementS006
Product CodeLOD
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address HOWMEDICA CORP. 359 Veterans Blvd. rutherford, NJ 07070

Supplemental Filings

Supplement NumberDateSupplement Type
N17004Original Filing
S013 2000-12-01 Real-time Process
S012 2000-05-23 Real-time Process
S011 1998-02-03 Normal 180 Day Track
S010 1997-10-17 Real-time Process
S009 1997-06-16 Normal 180 Day Track
S008 1996-11-18 Real-time Process
S007
S006 1994-09-26 Normal 180 Day Track
S005 1994-02-22 Normal 180 Day Track
S004 1993-05-21 Normal 180 Day Track
S003 1991-10-08 Normal 180 Day Track
S002 1990-04-30 Normal 180 Day Track
S001 1981-03-03

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