SOFTACT(TM) (DELTAFILCON A)
FDA premarket approval P800070/S001 · decided 1982-03-01
Approval details
- PMA number
- P800070
- Supplement
- S001
- Trade name
- SOFTACT(TM) (DELTAFILCON A)
- Generic name
- Lenses, soft contact, daily wear
- Applicant
- Premier Contact Lens
- Date received
- 1981-12-14
- Decision date
- 1982-03-01
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LPL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Nashville, TN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.