PMA P920004S007

Device
VASOSEAL (TM)
Applicant
St. Jude Medical, Inc.
PMA number
P920004
Supplement
S007
Product code
MGB
Decision date
1997-09-15
Generic name
Device, hemostasis, vascular
Approval order statement
Approval for expanding the range of device users to include health care professionals other than physicians.

Current openFDA PMA Record

Device
VASOSEAL (TM)
Applicant
St. Jude Medical, Inc.
PMA number
P920004
Supplement
S007
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
1997-09-15
Decision code
APPR
Date received
1997-08-08
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for expanding the range of device users to include health care professionals other than physicians.

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