PMA P000006S068

Device: Titan Inflatable Penile Prosthesis (IPP)
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S068
Product code: FHW
Decision date: 2024-07-09
Classification: Gastroenterology, Urology
Generic name: Device, impotence, mechanical/hydraulic
Approval order statement: Approval for introducing 24 cm and 26 cm sets with cylinders pre-connected to pumps, new packaging for the new pre-connected sets, and changes to the labeling and instructions for use to reflect the change in packaging.

Current openFDA PMA Record#

Device: Titan Inflatable Penile Prosthesis (IPP)
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S068
Product code: FHW
Generic name: Device, impotence, mechanical/hydraulic
Decision date: 2024-07-09
Decision code: APPR
Date received: 2024-04-19
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for introducing 24 cm and 26 cm sets with cylinders pre-connected to pumps, new packaging for the new pre-connected sets, and changes to the labeling and instructions for use to reflect the change in packaging.