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FDA PMA

Prosthesis, penis, inflatable

PMA Number: N970012 · 2026-09-14

ApplicantBoston Scientific Corp
Decision Date2026-09-14
PMA NumberN970012
Product CodeJCW
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeGU

Device Summary

Prosthesis, penis, inflatable is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2026-09-14. The device is classified under product code JCW. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the Prosthesis, penis, inflatable?

Prosthesis, penis, inflatable is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Boston Scientific Corp.

When did Prosthesis, penis, inflatable receive FDA 510(k) clearance?

The clearance date for Prosthesis, penis, inflatable can be found in the official FDA records.

Who is the listed applicant for Prosthesis, penis, inflatable?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prosthesis, penis, inflatable?

The FDA product code for Prosthesis, penis, inflatable is JCW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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