PMA P000006S034

Device: TITAN INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S034
Product code: FHW
Decision date: 2014-05-05
Classification: Device, Impotence, Mechanical/hydraulic
Generic name: Device, impotence, mechanical/hydraulic
Approval order statement: APPROVAL FOR AN ADDITIONAL RAW MATERIAL SUPPLIER FOR THE POLYURETHANE SPANDEX MATERIAL USED IN THE FABRICATION OF BIOFLEX® DISPERSION (USED TO MANUFACTURE TITAN RESERVOIRS AND CYLINDERS).

Current openFDA PMA Record#

Device: TITAN INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S034
Product code: FHW
Generic name: Device, impotence, mechanical/hydraulic
Decision date: 2014-05-05
Decision code: APPR
Date received: 2013-10-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN ADDITIONAL RAW MATERIAL SUPPLIER FOR THE POLYURETHANE SPANDEX MATERIAL USED IN THE FABRICATION OF BIOFLEX® DISPERSION (USED TO MANUFACTURE TITAN RESERVOIRS AND CYLINDERS).