BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0

Test, Urea Adult And Pediatric (breath),

FDA Premarket Approval P100025 S011

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

Change to the dmf for a raw material used to produce the finished drug component of the device.

DeviceBREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
Classification NameTest, Urea Adult And Pediatric (breath),
Generic NameTest, Urea Adult And Pediatric (breath),
ApplicantOTSUKA AMERICA PHARMACEUTICAL, INC.
Date Received2016-12-06
Decision Date2017-01-04
PMAP100025
SupplementS011
Product CodeOZA
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address OTSUKA AMERICA PHARMACEUTICAL, INC. 2440 Research Blvd. rockville, MD 20850

Supplemental Filings

Supplement NumberDateSupplement Type
P100025Original Filing
S014 2019-08-12 Normal 180 Day Track No User Fee
S013 2018-04-20 30-day Notice
S012 2017-01-09 Real-time Process
S011 2016-12-06 30-day Notice
S010 2015-09-15 Normal 180 Day Track
S009 2015-07-16 Normal 180 Day Track
S008 2015-01-13 Normal 180 Day Track
S007 2014-08-08 Normal 180 Day Track
S006 2014-01-22 Special (immediate Track)
S005 2013-06-28 Normal 180 Day Track
S004 2013-02-01 Normal 180 Day Track
S003 2012-10-12 Special (immediate Track)
S002 2012-08-31 Normal 180 Day Track No User Fee
S001 2012-03-19 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00857335005077 P100025 000
00857335005015 P100025 000
00857335005008 P100025 000
00840733101458 P100025 000
00840733101434 P100025 000

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