The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Tactra Penile Prosthesis, 9.5 Mm Device, Tactra Penile Prosthesis, 11 Mm Device, Tactra Penile Prosthesis, 13 Mm Device.
| Device ID | K183619 |
| 510k Number | K183619 |
| Device Name: | Tactra Penile Prosthesis, 9.5 Mm Device, Tactra Penile Prosthesis, 11 Mm Device, Tactra Penile Prosthesis, 13 Mm Device |
| Classification | Prosthesis, Penile |
| Applicant | Boston Scientific Corporation 10700 Bren Road West Minnetonka, MN 55343 |
| Contact | Laura Kelly |
| Correspondent | Laura Kelly Boston Scientific Corporation 10700 Bren Road West Minnetonka, MN 55343 |
| Product Code | FAE |
| CFR Regulation Number | 876.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-04-16 |