TETRAFILCON LENSES: PREFERENCE SPHERE
FDA premarket approval N17679/S036 · decided 2013-09-13
Approval details
- PMA number
- N17679
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TETRAFILCON LENSES: PREFERENCE SPHERE
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2013-08-19
- Decision date
- 2013-09-13
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- CHANGE TO THE STERILIZATION CYCLE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.