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PMA P000006S051

Device
Titan Inflatable Penile Prosthesis
Applicant
Coloplast Corp.
Product code
FHW
Decision date
2019-09-05
Generic name
Device, impotence, mechanical/hydraulic
Approval order statement
Approval to update the device labeling to incorporate instructions regarding the use of a manual modeling technique when the device is implanted in the presence of Peyronie’s Disease.

Current openFDA PMA Record#

Device
Titan Inflatable Penile Prosthesis
Applicant
Coloplast Corp.
PMA number
P000006
Supplement
S051
Product code
FHW
Generic name
Device, impotence, mechanical/hydraulic
Decision date
2019-09-05
Decision code
APPR
Date received
2019-06-24
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval to update the device labeling to incorporate instructions regarding the use of a manual modeling technique when the device is implanted in the presence of Peyronie’s Disease.