FDA Premarket Approval P170012 S023

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 a change to the bioburden determination method.

DeviceHEMOBLAST Bellows
Generic NameAbsorbable Collagen Hemostatic Agent With Thrombin
ApplicantBiom'Up France SAS
Date Received2020-04-29
Decision Date2020-09-11
Product CodePMX 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Biom'Up France SAS 8 Allee Irene Joliot Curie saint-priest 69800

Supplemental Filings

Supplement NumberDateSupplement Type
P170012Original Filing
S023 2020-04-29 135 Review Track For 30-day Notice
S022 2020-03-13 Real-time Process
S021 2019-12-27 30-day Notice
S020 2019-10-08 30-day Notice
S019 2019-08-15 30-day Notice
S018 2019-05-22 30-day Notice
S017 2019-04-22 30-day Notice
S016 2019-04-15 30-day Notice
S015 2019-02-11 30-day Notice
S014 2019-02-04 Special (immediate Track)
S013 2018-12-13 30-day Notice
S012 2018-10-30 30-day Notice
S011 2018-09-10 30-day Notice
S010 2018-08-27 30-day Notice
S009 2018-08-14 135 Review Track For 30-day Notice
S008 2018-07-09 30-day Notice
S007 2018-07-02 Normal 180 Day Track
S006 2018-06-29 Special (immediate Track)
S005 2018-06-15 30-day Notice
S004 2018-05-17 30-day Notice
S003 2018-04-12 30-day Notice
S002 2018-03-13 30-day Notice
S001 2018-02-23 Real-time Process

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