SOFT SITE (HEFILCON A) CONTACT LENS
FDA premarket approval N17793/S004 · decided 1981-06-25
Approval details
- PMA number
- N17793
- Supplement
- S004
- Trade name
- SOFT SITE (HEFILCON A) CONTACT LENS
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Unilens Corporation, USA
- Date received
- 1980-11-06
- Decision date
- 1981-06-25
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Largo, FL
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.