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MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042204
510(k) Type
Special
Applicant
EV3 INC
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
8/23/2004
Days to Decision
7 days
Submission Type
Summary

MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K042204
510(k) Type
Special
Applicant
EV3 INC
Country
United States
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
8/23/2004
Days to Decision
7 days
Submission Type
Summary