NEUROCONTROL FREEHAND SYSTEM

Stimulator, Neuromuscular, Implanted

FDA Premarket Approval P950035 S003

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

Approval for a new manufacturing site located at neurocontrol corporation, 8333 rockside road, valley view, oh.

DeviceNEUROCONTROL FREEHAND SYSTEM
Classification NameStimulator, Neuromuscular, Implanted
Generic NameStimulator, Neuromuscular, Implanted
ApplicantBIOCONTROL TECHNOLOGY, INC.
Date Received1998-12-02
Decision Date1999-01-19
PMAP950035
SupplementS003
Product CodeGZC
Advisory CommitteeEar Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BIOCONTROL TECHNOLOGY, INC. 1945 East 97th cleveland, OH 44106-4720

Supplemental Filings

Supplement NumberDateSupplement Type
P950035Original Filing
S010 2001-08-14 Special (immediate Track)
S009 2000-12-22 Normal 180 Day Track
S008 2000-07-11 Normal 180 Day Track
S007 2000-03-14 Real-time Process
S006 2000-02-29 Normal 180 Day Track
S005 1999-11-24 Real-time Process
S004 1999-04-07 Normal 180 Day Track
S003 1998-12-02 Normal 180 Day Track
S002 1998-06-29 Special (immediate Track)
S001 1998-02-10 Real-time Process

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