LifePulse High Frequency Ventilator

FDA Premarket Approval P850064 S046

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

New process using the 844usb epro programmer

DeviceLifePulse High Frequency Ventilator
Generic NameVentilator, High Frequency
ApplicantBUNNELL, INC.
Date Received2021-05-27
Decision Date2021-06-25
PMAP850064
SupplementS046
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
S046 2021-05-27 30-day Notice
S045
S044 2021-01-28 30-day Notice
S043 2020-10-29 30-day Notice
S042 2019-11-15 30-day Notice
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
10616120000089 P850064 000
00616120000020 P850064 000
00616120000006 P850064 000
00616120000013 P850064 017
00616120000112 P850064 028
00616120000105 P850064 028

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