POLYTEF PASTE FOR INJECTION
FDA premarket approval N16420/S005 · decided 2001-05-30
Approval details
- PMA number
- N16420
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POLYTEF PASTE FOR INJECTION
- Generic name
- PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
- Applicant
- Coloplast Corp.
- Date received
- 2000-12-26
- Decision date
- 2001-05-30
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- LTG
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Plymouth, MN
- 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.
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