LifePulse High Frequency Ventilator

Ventilator, High Frequency

FDA Premarket Approval P850064 S041

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

For the lifepulse high frequency ventilator (hfv), to notify of a change to the manufacturing process and manufacturer of the priority alarm cover. The priority alarm cover is specific to the hfv 204

DeviceLifePulse High Frequency Ventilator
Classification NameVentilator, High Frequency
Generic NameVentilator, High Frequency
ApplicantBUNNELL, INC.
Date Received2019-10-24
Decision Date2019-11-22
PMAP850064
SupplementS041
Product CodeLSZ
Advisory CommitteeAnesthesiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BUNNELL, INC. 436 Lawndale Dr. salt Lake City, UT 84115

Supplemental Filings

Supplement NumberDateSupplement Type
P850064Original Filing
S041 2019-10-24 30-day Notice
S040
S039 2019-02-27 135 Review Track For 30-day Notice
S038 2018-10-25 30-day Notice
S037 2018-09-20 30-day Notice
S036 2018-01-29 Real-time Process
S035 2017-10-02 Real-time Process
S034 2017-06-07 30-day Notice
S033 2016-07-22 30-day Notice
S032 2016-05-24 Real-time Process
S031 2016-02-24 Real-time Process
S030 2015-03-31 Normal 180 Day Track
S029 2015-02-18 30-day Notice
S028 2015-02-04 Normal 180 Day Track
S027 2014-08-25 Normal 180 Day Track No User Fee
S026 2014-01-27 30-day Notice
S025 2013-09-09 30-day Notice
S024
S023 2013-06-10 Normal 180 Day Track
S022
S021 2012-09-07 Normal 180 Day Track
S020
S019
S018 2010-02-22 Normal 180 Day Track
S017 2001-04-04 Normal 180 Day Track
S016 1999-09-10 Special (immediate Track)
S015 1998-10-21 Normal 180 Day Track
S014 1998-08-28 Special (immediate Track)
S013
S012 1997-04-11 Special (immediate Track)
S011 1995-04-05 Normal 180 Day Track
S010 1994-08-05 Normal 180 Day Track
S009 1992-11-27 Normal 180 Day Track
S008
S007
S006 1991-08-01 Normal 180 Day Track
S005 1990-10-01 Normal 180 Day Track
S004
S003 1989-07-24 Normal 180 Day Track
S002 1989-02-09 Normal 180 Day Track
S001 1988-09-19 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00616120000006 P850064 000
10616120000089 P850064 000
00616120000020 P850064 000
00616120000006 P850064 000
00616120000020 P850064 000
10616120000089 P850064 000
00616120000013 P850064 017
00616120000013 P850064 017
00616120000105 P850064 028
00616120000112 P850064 028
00616120000105 P850064 028
00616120000112 P850064 028

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