~[24~R DIRECT CURRENT BONE GROWTH STIMULATOR

FDA Premarket Approval P790008 S005

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

Device~[24~R DIRECT CURRENT BONE GROWTH STIMULATOR
Generic NameStimulator, Invasive Bone Growth
ApplicantZIMMER, INC.
Date Received1989-09-06
Decision Date1991-03-29
PMAP790008
SupplementS005
Product CodeLOE 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708

Supplemental Filings

Supplement NumberDateSupplement Type
P790008Original Filing
S005 1989-09-06 Normal 180 Day Track
S004 1988-03-02 30-Day Supplement
S003 1982-07-29 Normal 180 Day Track
S002
S001 1982-03-08 Normal 180 Day Track

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