KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE

FDA Premarket Approval P850069 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

DeviceKENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE
Generic NameLigaments And Tendons, Synthetic
Applicant3M COMPANY
Date Received1989-12-26
Decision Date1992-12-31
Notice Date1993-05-03
PMAP850069
SupplementS006
Product CodeLML 
Docket Number93M-0018
Advisory CommitteePhysical Medicine
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address 3M COMPANY 3m Center bldg. 275-3se-08 st. Paul, MN 55144-1000

Supplemental Filings

Supplement NumberDateSupplement Type
P850069Original Filing
S011 1994-05-20 Normal 180 Day Track
S010 1994-01-21 Normal 180 Day Track
S009 1991-09-13 Normal 180 Day Track
S008 1991-12-12 Normal 180 Day Track
S007 1989-08-25 Normal 180 Day Track
S006 1989-12-26 Panel Track
S005 1989-12-13 Normal 180 Day Track
S004 1989-06-02 Normal 180 Day Track
S003 1988-10-19 Normal 180 Day Track
S002 1988-08-08 Normal 180 Day Track
S001 1988-05-09 Normal 180 Day Track

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