P.C.A.(TM) TOTAL KNEE SYSTEM

FDA Premarket Approval P840049

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceP.C.A.(TM) TOTAL KNEE SYSTEM
Generic NameProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
ApplicantHOWMEDICA CORP.
Date Received1984-10-09
Decision Date1988-09-30
Notice Date1988-12-16
PMAP840049
SupplementS
Product CodeHRY 
Docket Number88M-0364
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address HOWMEDICA CORP. 359 Veterans Blvd. rutherford, NJ 07070

Supplemental Filings

Supplement NumberDateSupplement Type
P840049Original Filing
S001 1989-05-03 Normal 180 Day Track

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