HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT

Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Approval P850023

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceHEMOPAD ABSORBABLE COLLAGEN HEMOSTAT
Classification NameAgent, Absorbable Hemostatic, Collagen Based
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantDatascope Corp.
Date Received1985-04-17
Decision Date1986-05-27
Notice Date1986-07-07
PMAP850023
SupplementS
Product CodeLMF
Docket Number86M-0248
Advisory CommitteeGeneral & Plastic Surgery
Expedited ReviewNo
Combination Product No
Applicant Address Datascope Corp. 14 Philips Pkwy. montvale, NJ 07645

Supplemental Filings

Supplement NumberDateSupplement Type
P850023Original Filing
S014 1994-06-27 Normal 180 Day Track
S013 1992-05-22 Normal 180 Day Track
S012
S011 1991-07-26 Normal 180 Day Track
S010 1991-07-12 Normal 180 Day Track
S009 1989-12-08 Normal 180 Day Track
S008 1988-09-06 Normal 180 Day Track
S007
S006 1987-10-22 Normal 180 Day Track
S005 1987-09-04 Normal 180 Day Track
S004 1987-06-17 Normal 180 Day Track
S003 1987-03-26 Normal 180 Day Track
S002 1986-10-29 Normal 180 Day Track
S001 1986-08-12 30-Day Supplement

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