PMA P000006S011
- Device
- COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S011
- Product code
- FHW
- Decision date
- 2008-09-16
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- APPROVAL FOR CHANGES TO THE ¿SHELF LIFE PROGRAM FOR THE TITAN INFLATABLE PENILE PROSTHESIS ¿ 60 DEGREES C ACCELERATED AND REAL TIME AGING¿ (I.E., SHELF LIFE TESTING PROTOCOL; DOCUMENT ¿MUS 085:065¿), UPDATED TO INCORPORATE THE TEST PARAMETERS FOR THE ONE-TOUCH RELEASE (OTR) PUMP.
Current openFDA PMA Record#
- Device
- COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S011
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2008-09-16
- Decision code
- APPR
- Date received
- 2008-08-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE ¿SHELF LIFE PROGRAM FOR THE TITAN INFLATABLE PENILE PROSTHESIS ¿ 60 DEGREES C ACCELERATED AND REAL TIME AGING¿ (I.E., SHELF LIFE TESTING PROTOCOL; DOCUMENT ¿MUS 085:065¿), UPDATED TO INCORPORATE THE TEST PARAMETERS FOR THE ONE-TOUCH RELEASE (OTR) PUMP.