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FDA 510(k)

MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH

K-Number: K040521 · 2004-03-24

ApplicantAmerican Medical Systems, Inc.
Decision Date2004-03-24
Product CodeOTP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 2004-03-24 under 510(k) number K040521. The device is classified under product code OTP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH?

MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH is a medical device that received FDA 510(k) clearance on 2004-03-24. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K040521.

When did MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH receive FDA 510(k) clearance?

MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH received FDA 510(k) clearance on 2004-03-24, under 510(k) number K040521.

Who is the listed applicant for MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH?

The FDA 510(k) record lists American Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH?

The FDA product code for MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH is OTP.

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Related Devices (Code: OTP)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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