ZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT

FDA Premarket Approval N17755 S042

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

DeviceZIMMER DOUGH TYPE & L.V.C.(R) BONE CEMENT
Generic NameBone Cement
ApplicantZIMMER, INC.
Date Received1994-06-13
Decision Date1995-06-09
PMAN17755
SupplementS042
Product CodeLOD 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708

Supplemental Filings

Supplement NumberDateSupplement Type
N17755Original Filing
S049 1997-05-01 Normal 180 Day Track
S048 1996-08-30 Normal 180 Day Track
S047 1996-06-21 Real-time Process
S046 1995-10-11 Special (immediate Track)
S045 1995-06-22 Normal 180 Day Track
S044 1994-08-01 Normal 180 Day Track
S043 1994-07-08 Special (immediate Track)
S042 1994-06-13 Normal 180 Day Track
S041 1992-09-18 Normal 180 Day Track
S040 1992-05-28 Special (immediate Track)
S039 1992-02-18 Normal 180 Day Track
S038
S037 1990-02-08 Normal 180 Day Track
S036 1990-01-12 Normal 180 Day Track
S035 1990-01-08 Special (immediate Track)
S034 1988-04-12 30-Day Supplement
S033 1986-09-03 Normal 180 Day Track
S032
S031 1984-08-24
S030
S029 1983-01-03
S028 1982-10-26
S027 1982-08-18
S026 1982-08-06
S025 1982-07-07
S024 1982-02-11
S023
S022 1981-06-29
S021 1981-05-22
S020
S019 1980-09-01
S018
S017
S016
S015
S014
S013
S012
S011
S010
S009
S008
S007
S006
S005
S004
S003
S002
S001

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.