PMA P000006S013

Device: TITAN INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S013
Product code: FHW
Decision date: 2008-12-22
Classification: Device, Impotence, Mechanical/hydraulic
Generic name: Device, impotence, mechanical/hydraulic
Approval order statement: USE OF A NEW METHOD FOR MARKING THE SALINE FILLED TESTICULAR PROSTHESIS AND THE TITAN INFLATABLE PENILE PROSTHESIS AND FOR BORING SUTURE HOLES ON THE TITAN INFLATABLE PENILE PROSTHESIS.

Current openFDA PMA Record#

Device: TITAN INFLATABLE PENILE PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P000006
Supplement: S013
Product code: FHW
Generic name: Device, impotence, mechanical/hydraulic
Decision date: 2008-12-22
Decision code: OK30
Date received: 2008-11-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: USE OF A NEW METHOD FOR MARKING THE SALINE FILLED TESTICULAR PROSTHESIS AND THE TITAN INFLATABLE PENILE PROSTHESIS AND FOR BORING SUTURE HOLES ON THE TITAN INFLATABLE PENILE PROSTHESIS.