Absorbable Collagen Hemostatic Agent With Thrombin

FDA Premarket Approval P170012 S020

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

Changes involving reorganization of the workflow in the hemoblast bellows manufacturing facility (st-priest, france), mainly for the purpose of efficientlyutilizing the fixed space in the facility.

DeviceHEMOBLAST Bellows
Classification NameAbsorbable Collagen Hemostatic Agent With Thrombin
Generic NameAbsorbable Collagen Hemostatic Agent With Thrombin
ApplicantBiom'Up SA
Date Received2019-10-08
Decision Date2019-11-07
Product CodePMX
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Biom'Up SA 120 Brimful Drive phoenixville, PA 19460

Supplemental Filings

Supplement NumberDateSupplement Type
P170012Original Filing
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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