Last synced on 25 November 2022 at 11:04 pm

Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183619
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/16/2019
Days to Decision
111 days
Submission Type
Summary

Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183619
510(k) Type
Traditional
Applicant
Boston Scientific Corporation
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/16/2019
Days to Decision
111 days
Submission Type
Summary