POLYMACON EXTENDED-WEAR LENSES
FDA premarket approval P780007/S053 · decided 2015-01-09
Approval details
- PMA number
- P780007
- Supplement
- S053
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POLYMACON EXTENDED-WEAR LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2013-11-13
- Decision date
- 2015-01-09
- Days to decision
- 422 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR A NEW TEST METHOD FOR BIOBURDEN ENUMERATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.