iWear oxygen and iWear oxygen astigmatism
FDA premarket approval P080011/S058 · decided 2017-05-05
Approval details
- PMA number
- P080011
- Supplement
- S058
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- iWear oxygen and iWear oxygen astigmatism
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2017-03-27
- Decision date
- 2017-05-05
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for labeling change to add new private label brand name, iWear oxygen and iWear oxygen astigmatism. The name iWear oxygen is intended for the spherical lenses and iWear oxygen astigmatism for the toric lenses.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.