Ams 700 Series Product Line and the Dynaflex Inflatable Penile Prostheses

FDA premarket approval N970012 · Prosthesis, penis, inflatable

PMA numberN970012

Approval

Applicant
Boston Scientific Corp
Received
December 22, 1997
Decision date
November 2, 1998 (APPR)
Supplements
130, latest May 18, 2026
Product code
JCW – Prosthesis, Penis, Inflatable

Official FDA PMA record

Approval order statement

APPROVAL FOR THE AMS 700 SERIES INFLATABLE PENILE PROSTHESIS PRODUCT LINE. THIS DEVICE IS INDICATED FOR USE IN THE TREATMENT OF CHRONIC, ORGANIC, MALE ERECTILE DYSFUNCTION (IMPOTENCE).