PMA P780007S053
- Device
- POLYMACON EXTENDED-WEAR LENSES
- Applicant
- CooperVision, Inc.
- PMA number
- P780007
- Supplement
- S053
- Product code
- LPM
- Decision date
- 2015-01-09
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- APPROVAL FOR A NEW TEST METHOD FOR BIOBURDEN ENUMERATION.
Current openFDA PMA Record#
- Device
- POLYMACON EXTENDED-WEAR LENSES
- Applicant
- CooperVision, Inc.
- PMA number
- P780007
- Supplement
- S053
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2015-01-09
- Decision code
- APPR
- Date received
- 2013-11-13
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A NEW TEST METHOD FOR BIOBURDEN ENUMERATION.