DIAPHAGMATIC/PHRENIC NERVE STIMULATOR

Implanted Diaphragmatic/phrenic Nerve Stimulator

FDA Premarket Approval P860026 S007

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 changing the method of attaching the battery connector and wiring from the power switches to the printed circuit board, changing the point where the signal is taken to illuminate the battery led indicator, adding the energy source routing to the front panel of the respiratory rate control circuitry, changing the point whee the battery power is obtained for each stimulator output amplifier circuit, and decreasing the sensitivity of the oscillator circuit to transistor output capacitance. The device, as modified, will be marketed under the trade name mark iv and is indicated for persons who require chronic ventilatory support because of upper motor neuron respiratory muscle paralysis (rmp) or because of central alveolar hypoventilation (cah) and whose remaining phrenic nerve, lung, and diaphragm function is sufficient to accomodate electrical stimulation.

DeviceDIAPHAGMATIC/PHRENIC NERVE STIMULATOR
Classification NameImplanted Diaphragmatic/phrenic Nerve Stimulator
Generic NameImplanted Diaphragmatic/phrenic Nerve Stimulator
ApplicantAVERY BIOMEDICAL DEVICES, INC.
Date Received2000-11-16
Decision Date2001-01-26
PMAP860026
SupplementS007
Product CodeGZE
Advisory CommitteeAnesthesiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address AVERY BIOMEDICAL DEVICES, INC. 61 Mall Dr. commack, NY 11725-5703

Supplemental Filings

Supplement NumberDateSupplement Type
P860026Original Filing
S009 2017-09-27 Normal 180 Day Track
S008 2002-09-11 Normal 180 Day Track
S007 2000-11-16 Real-time Process
S006 2000-04-27 Normal 180 Day Track
S005 1995-07-07 Normal 180 Day Track
S004 1993-08-10 Normal 180 Day Track
S003 1991-05-28 Normal 180 Day Track
S002 1990-09-17 Normal 180 Day Track
S001 1989-04-05 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00850252006059 P860026 005
00850252006042 P860026 005
00850252006035 P860026 005
00850252006028 P860026 006
00850252006011 P860026 006
00850252006004 P860026 008
00850252006066 P860026 009

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