PMA N970012S110

Device: AMS 700, AMS AMBICOR, AMS 700 WITH MS PUMP INFLATABLE PENILE PROSTHESIS (IPP)
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S110
Product code: FHW
Decision date: 2015-08-04
Classification: Device, Impotence, Mechanical/hydraulic
Generic name: Device, impotence, mechanical/hydraulic
Approval order statement: APPROVAL FOR MODIFICATION OF THE INSTRUCTIONS FOR USE TO EXPAND THE ADVERSE DEVICE EFFECTS INFORMATION TO REFLECT NEWLY ACQUIRED INFORMATION.

Current openFDA PMA Record#

Device: AMS 700, AMS AMBICOR, AMS 700 WITH MS PUMP INFLATABLE PENILE PROSTHESIS (IPP)
Applicant: Boston Scientific Corp
PMA number: N970012
Supplement: S110
Product code: FHW
Generic name: Device, impotence, mechanical/hydraulic
Decision date: 2015-08-04
Decision code: APPR
Date received: 2015-07-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATION OF THE INSTRUCTIONS FOR USE TO EXPAND THE ADVERSE DEVICE EFFECTS INFORMATION TO REFLECT NEWLY ACQUIRED INFORMATION.