PMA P780007S045
- Device
- BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
- Applicant
- CooperVision, Inc.
- PMA number
- P780007
- Supplement
- S045
- Product code
- LPM
- Decision date
- 2011-05-13
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- UTILIZE THE DYE PENETRATION TEST METHOD FOR TESTING PACKAGE INTEGRITY.
Current openFDA PMA Record#
- Device
- BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
- Applicant
- CooperVision, Inc.
- PMA number
- P780007
- Supplement
- S045
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2011-05-13
- Decision code
- OK30
- Date received
- 2011-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UTILIZE THE DYE PENETRATION TEST METHOD FOR TESTING PACKAGE INTEGRITY.