JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR
FDA premarket approval P040029/S001 · decided 2005-10-14
Approval details
- PMA number
- P040029
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Euclid Vision Corporation
- Date received
- 2005-08-29
- Decision date
- 2005-10-14
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Sterling, VA
- Statement
- APPROVAL FOR A PROTOCOL OF ACCEPTABLE PROCEDURES TO ALLOW ONE OR MORE INDEPENDENT FINISHING LABORATORIES TO MANUFACTURE AND DISTRIBUTE FINISHED RGP CONTACT LENSES FOR OVERNIGHT ORTHOKERATOLOGY MADE FROM LENS BLANKS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.