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.

• Device: DIAPHAGMATIC/PHRENIC NERVE STIMULATOR
• Classification Name: Implanted Diaphragmatic/phrenic Nerve Stimulator
• Generic Name: Implanted Diaphragmatic/phrenic Nerve Stimulator
• Applicant: AVERY BIOMEDICAL DEVICES, INC.
• Date Received: 2000-11-16
• Decision Date: 2001-01-26
• PMA: P860026
• Supplement: S007
• Product Code: GZE
• Advisory Committee: Anesthesiology
• Supplement Type: Real-time Process
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: AVERY BIOMEDICAL DEVICES, INC. 61 Mall Dr. commack, NY 11725-5703

Supplemental Filings

Supplement Number	Date	Supplement Type
P860026		Original 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 ID	PMA	Supp
00850252006059	P860026	005
00850252006042	P860026	005
00850252006035	P860026	005
00850252006028	P860026	006
00850252006011	P860026	006
00850252006004	P860026	008
00850252006066	P860026	009