PMA N16420S006

Device: MENTOR POLYTEF PASTE /FOR INJECTION
Applicant: Coloplast Corp.
PMA number: N16420
Supplement: S006
Product code: LTG
Decision date: 2001-11-21
Generic name: PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
Approval order statement: APPROVAL FOR RELOCATION OF THE FORMULATION OF THE BULK PASTE AND THE EQUIPMENT AND PROCESSES ASSOCIATED WITH COMPOUNDING TO MENTOR, MINEAPOLIS, MINNISOTA.

Current openFDA PMA Record#

Device: MENTOR POLYTEF PASTE /FOR INJECTION
Applicant: Coloplast Corp.
PMA number: N16420
Supplement: S006
Product code: LTG
Generic name: PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
Decision date: 2001-11-21
Decision code: APPR
Date received: 2001-10-26
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR RELOCATION OF THE FORMULATION OF THE BULK PASTE AND THE EQUIPMENT AND PROCESSES ASSOCIATED WITH COMPOUNDING TO MENTOR, MINEAPOLIS, MINNISOTA.