FDA.reportPublic FDA data

PMA P000006S064

Device
Titan Inflatable Penile Prosthesis (IPP)
Applicant
Coloplast Corp.
Product code
FHW
Decision date
2023-03-03
Generic name
Device, impotence, mechanical/hydraulic
Approval order statement
Approval for changes to the packaging to include new or modified components in the prosthesis assembly kits and to reorganize the packaging of these assembly kits, and changes to the instructions for use to accommodate the new assembly kits as well as reorganization of content.

Current openFDA PMA Record#

Device
Titan Inflatable Penile Prosthesis (IPP)
Applicant
Coloplast Corp.
PMA number
P000006
Supplement
S064
Product code
FHW
Generic name
Device, impotence, mechanical/hydraulic
Decision date
2023-03-03
Decision code
APPR
Date received
2022-12-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes to the packaging to include new or modified components in the prosthesis assembly kits and to reorganize the packaging of these assembly kits, and changes to the instructions for use to accommodate the new assembly kits as well as reorganization of content.