Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: MENTOR POLYTEF PASTE FOR INJECTION
• Generic Name: PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
• Applicant: Coloplast Corp.; 1601 W. River Rd. N.; Plymouth, MN 55411
• PMA Number: N16420
• Supplement Number: S001
• Date Received: 05/23/1983
• Decision Date: 12/20/1983
• Withdrawal Date: 10/02/2009
• Product Code: LTG
• Advisory Committee: Ear Nose & Throat
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No