PMA P000006S004
- Device
- MENTOR INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S004
- Product code
- FHW
- Decision date
- 2004-04-28
- Classification
- Device, Impotence, Mechanical/hydraulic
- Generic name
- Device, impotence, mechanical/hydraulic
- Approval order statement
- CHANGE IN THE RAW MATERIAL SUPPLIER OF A CHEMICAL USED IN THE MANUFACTURING OF MENTOR'S INFLATABLE PENILE PROSTHESIS.
Current openFDA PMA Record#
- Device
- MENTOR INFLATABLE PENILE PROSTHESIS
- Applicant
- Coloplast Corp.
- PMA number
- P000006
- Supplement
- S004
- Product code
- FHW
- Generic name
- Device, impotence, mechanical/hydraulic
- Decision date
- 2004-04-28
- Decision code
- OK30
- Date received
- 2004-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE RAW MATERIAL SUPPLIER OF A CHEMICAL USED IN THE MANUFACTURING OF MENTOR'S INFLATABLE PENILE PROSTHESIS.