AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™, AMS Ambicor Inflatable Pe

FDA premarket approval N970012/S196 · decided 2023-09-20

Approval details

PMA number

N970012

Supplement

S196

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™, AMS Ambicor Inflatable Pe

Generic name

Prosthesis, penis, inflatable

Applicant

Boston Scientific Corp

Date received

2023-03-24

Decision date

2023-09-20

Days to decision

180 days

Decision code

APPR

Product code

JCW

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Marlboro, MA

Statement

Approval for 1) an update to the AMS 700 product labeling to include an alternative implant location for the AMS 700 reservoir. The AMS 700 reservoir is a component of the AMS 700 system and is available with or without the drug treatment known as InhibiZone; and 2) an update to the AMS 700 product labeling and the AMS Ambicor product labeling to include new parameters for safe magnetic resonance scanning of a patient implanted with an AMS 700 system or an AMS Ambicor device.

510(k) clearances by this applicant