BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
FDA premarket approval P080011/S011 · decided 2012-05-11
Approval details
- PMA number
- P080011
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2012-03-30
- Decision date
- 2012-05-11
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- REVALIDATION OF BIOFINITY MANUFACTURING LINE #4 WITH THE FOLLOWING MANUFACTURING CHANGES: 1) AN INCREASE IN TEMPERATURE OF THE BARREL HEATER ON THE INJECTION MOLDING MACHINE; AND 2) A CONSOLIDATION CHANGE IN THE DESIGN OF THE FILL AND CLOSE MODULE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.