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ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121612
510(k) Type
Special
Applicant
AMERICAN MEDICAL SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/20/2012
Days to Decision
49 days
Submission Type
Summary

ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121612
510(k) Type
Special
Applicant
AMERICAN MEDICAL SYSTEMS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/20/2012
Days to Decision
49 days
Submission Type
Summary