POLYMACON CONTACT LENSES
FDA premarket approval P780007/S041 · decided 1996-09-27
Approval details
- PMA number
- P780007
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POLYMACON CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1996-02-06
- Decision date
- 1996-09-27
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fairport, NY
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE REFERENCED DEVICE AT RELIANT CLOSE, CHANDLERS FORD INDUSTRIAL ESTATE, CHANDLERS FORD, EASTLEIGH, HAMPSHIRE, S053 4ND, ENGLAND
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.