PMA N970012S196

Device: AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™, AMS Ambicor Inflatable Pe
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S196
Product code: JCW
Decision date: 2023-09-20
Classification: Gastroenterology, Urology
Generic name: Prosthesis, penis, inflatable
Approval order 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.

Current openFDA PMA Record#

Device: AMS 700™ Inflatable Penile Prosthesis, AMS 700™ Inflatable Penile Prosthesis with InhibiZone™, AMS Ambicor Inflatable Pe
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S196
Product code: JCW
Generic name: Prosthesis, penis, inflatable
Decision date: 2023-09-20
Decision code: APPR
Date received: 2023-03-24
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.