PMA N16420S005

Device: POLYTEF PASTE FOR INJECTION
Applicant: Coloplast Corp.
PMA number: N16420
Supplement: S005
Product code: LTG
Decision date: 2001-05-30
Generic name: PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT MENTOR CORPORATION, MINNEAPOLIS, MN, AND APPROVAL FOR TWO STERILIZATION SITES LOCATED AT STERIS ISOMEDIX, INC., MINNEAPOLIS, MN, AND BIOTEST LABORATORIES, INC., MINNEAPOLIS, MN.

Current openFDA PMA Record#

Device: POLYTEF PASTE FOR INJECTION
Applicant: Coloplast Corp.
PMA number: N16420
Supplement: S005
Product code: LTG
Generic name: PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
Decision date: 2001-05-30
Decision code: APPR
Date received: 2000-12-26
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT MENTOR CORPORATION, MINNEAPOLIS, MN, AND APPROVAL FOR TWO STERILIZATION SITES LOCATED AT STERIS ISOMEDIX, INC., MINNEAPOLIS, MN, AND BIOTEST LABORATORIES, INC., MINNEAPOLIS, MN.