Avery Diaphragm Pacing System (alson known as Breathing Pacemaker System)

Implanted Diaphragmatic/phrenic Nerve Stimulator

FDA Premarket Approval P860026 S009

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 to replace the mark iv transmitter with the digital spirit transmitter.

DeviceAvery Diaphragm Pacing System (alson known as Breathing Pacemaker System)
Classification NameImplanted Diaphragmatic/phrenic Nerve Stimulator
Generic NameImplanted Diaphragmatic/phrenic Nerve Stimulator
Date Received2017-09-27
Decision Date2019-11-04
Product CodeGZE
Advisory CommitteeAnesthesiology
Supplement TypeNormal 180 Day Track
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


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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