PMA P000006S070

Device: Titan Inflatable Penile Prosthesis
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S070
Product code: FHW
Decision date: 2025-05-28
Classification: Gastroenterology, Urology
Generic name: Device, impotence, mechanical/hydraulic
Approval order statement: approval for an alternate sterilization site for the Titan Inflatable Penile Prosthesis Assembly Kits and Rear Tips Extenders at Sterigenics, West Memphis, Arkansas.

Current openFDA PMA Record#

Device: Titan Inflatable Penile Prosthesis
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S070
Product code: FHW
Generic name: Device, impotence, mechanical/hydraulic
Decision date: 2025-05-28
Decision code: APPR
Date received: 2024-11-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for an alternate sterilization site for the Titan Inflatable Penile Prosthesis Assembly Kits and Rear Tips Extenders at Sterigenics, West Memphis, Arkansas.