VASCUTEK GELSOFT(TM) VASCULAR GRAFT

Graft, Vascular, Synthetic/biologic Composite

FDA Premarket Approval P890045 S001

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

Applying the gelatin coating to the vascusoft, a different substrate graft. The modified device will be marketed under trade name:vascutek gelsoft vascular graft

DeviceVASCUTEK GELSOFT(TM) VASCULAR GRAFT
Classification NameGraft, Vascular, Synthetic/biologic Composite
Generic NameGraft, Vascular, Synthetic/biologic Composite
ApplicantCARBOMEDICS, INC.
Date Received1993-07-08
Decision Date1995-07-05
PMAP890045
SupplementS001
Product CodeMAL
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CARBOMEDICS, INC. 1300-d East Anderson Ln. austin, TX 78752

Supplemental Filings

Supplement NumberDateSupplement Type
P890045Original Filing
S006 1994-04-18 Normal 180 Day Track
S005 1994-03-31 Normal 180 Day Track
S004
S003 1993-11-05 Normal 180 Day Track
S002
S001 1993-07-08 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05037881110585 P890045 000
05037881101194 P890045 000
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