COSTASIS/DYNASTAT SURGICAL HEMOSTAT

Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Approval P990030 S002

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 modifications to the costasis(r)/dynastat(tm) surgical hemostats' product labeling.

DeviceCOSTASIS/DYNASTAT SURGICAL HEMOSTAT
Classification NameAgent, Absorbable Hemostatic, Collagen Based
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantANGIOTECH MEDICAL DEVICE TECHNOLOGIES
Date Received2001-11-20
Decision Date2001-12-21
PMAP990030
SupplementS002
Product CodeLMF
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ANGIOTECH MEDICAL DEVICE TECHNOLOGIES 3600 S.w 47th Avenue gainesville, FL 32608

Supplemental Filings

Supplement NumberDateSupplement Type
P990030Original Filing
S005 2004-08-23 Normal 180 Day Track No User Fee
S004 2002-04-30 Normal 180 Day Track
S003 2001-12-27 Normal 180 Day Track
S002 2001-11-20 Special (immediate Track)
S001 2000-10-18 Real-time Process

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