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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameFLOSEAL MATRIX(R)/PROCEED(R) HEMOSTATIC SEALANTS (DRY FORM)
Classification Nameagent, absorbable hemostatic, collagen based
Generic Namefusion matrix-dry
Regulation Number878.4490
ApplicantFUSION MEDICAL TECHNOLOGIES, INC.
PMA NumberP990009
Supplement NumberS009
Date Received06/26/2001
Decision Date08/10/2001
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an increase in an intermediate specification for residual glutaraldehyde from 20 to 40 ppm, the removal of the neurosurgical exclusion from the indications statement and the addition of the nasal/sinus instructions and inormation to the labeling of the "dry" form of the fusion matrix product.
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