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ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEMS

FDA premarket approval P990017/S012 · decided 2001-02-15

Approval details

PMA number
P990017
Supplement
S012
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
ANCURE TUBE AND BIFURCATED ENDOGRAFT SYSTEMS
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Applicant
Boston Scientific Corp
Date received
2000-11-06
Decision date
2001-02-15
Days to decision
101 days
Decision code
APPR
Product code
MIH
Advisory committee
Cardiovascular
Expedited review
No
Location
St Paul, MN
Statement
APPROVAL FOR A MODIFICATION TO THE TRAINING PROGRAM TO ALLOW LESS THAN 100% CASE SUPPORT AT CENTERS THAT MEET THE ESTABLISHED CRITERIA. THIS CHANGE AFFECTS THE CONDITIONS OF APPROVAL DESCRIBED IN THE ORIGINAL APPROVAL ORDER, DATED SUPTEMBER 28, 1999.

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510(k) clearances by this applicant

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EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (K150679)Boston Scientific Corp2015-05-29
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