PMA N970012S197

Device: AMS 700 Inflatable Penile Prosthesis (with and without InhibiZone)
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S197
Product code: JCW
Decision date: 2023-11-14
Classification: Gastroenterology, Urology
Generic name: Prosthesis, penis, inflatable
Approval order statement: Approval to commercialize a next generation pump design, the TENACIO Pump, for use in the AMS 700 Inflatable Penile Prosthesis (IPP).

Current openFDA PMA Record#

Device: AMS 700 Inflatable Penile Prosthesis (with and without InhibiZone)
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S197
Product code: JCW
Generic name: Prosthesis, penis, inflatable
Decision date: 2023-11-14
Decision code: APPR
Date received: 2023-03-31
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to commercialize a next generation pump design, the TENACIO Pump, for use in the AMS 700 Inflatable Penile Prosthesis (IPP).