NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT

Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Approval P850023 S008

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

DeviceNOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT
Classification NameAgent, Absorbable Hemostatic, Collagen Based
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantDatascope Corp.
Date Received1988-09-06
Decision Date1989-03-09
PMAP850023
SupplementS008
Product CodeLMF
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
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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