PMA P020003S006

Device: SALINE FILLED TESTICULAR PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P020003
Supplement: S006
Product code: FAF
Decision date: 2008-12-22
Classification: Prosthesis, Testicular
Generic name: Prosthesis, testicular
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: SALINE FILLED TESTICULAR PROSTHESIS
Applicant: Coloplast Corp.
PMA number: P020003
Supplement: S006
Product code: FAF
Generic name: Prosthesis, testicular
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.