PMA N16420
- Device
- MENTOR POLYTEF PASTE FOR INJECTION
- Applicant
- Coloplast Corp.
- PMA number
- N16420
- Supplement
- S007
- Product code
- LTG
- Decision date
- 2005-01-03
- Generic name
- PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
- Approval order statement
- CHANGE IN VENDOR OF A RAW MATERIAL FOR POLYTEF PASTE FOR INJECTION.
Current openFDA PMA Record#
- Device
- MENTOR POLYTEF PASTE FOR INJECTION
- Applicant
- Coloplast Corp.
- PMA number
- N16420
- Supplement
- S007
- Product code
- LTG
- Generic name
- PASTE, INJECTABLE FOR VOCAL CORD AUGMENTATION
- Decision date
- 2005-01-03
- Decision code
- OK30
- Date received
- 2004-12-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN VENDOR OF A RAW MATERIAL FOR POLYTEF PASTE FOR INJECTION.