VANTAGE (TETRAFILCON A ) CONTACT LENS
FDA premarket approval N17679/S032 · decided 1998-07-02
Approval details
- PMA number
- N17679
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VANTAGE (TETRAFILCON A ) CONTACT LENS
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1998-02-17
- Decision date
- 1998-07-02
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval for the following: 1)Aspect Vision Care, Ltd., Hamble, United Kingdom as an alternate manufacturing site; 2)an alternate manufacturing process of fully molded; 3)a change in the initiator used in the polymerization method; and 4)expansion of the parameter range.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.