RingJect
FDA premarket approval P030023/S006 · decided 2019-04-30
Approval details
- PMA number
- P030023
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RingJect
- Generic name
- Ring, endocapsular
- Applicant
- Ophtec BV
- Date received
- 2018-05-04
- Decision date
- 2019-04-30
- Days to decision
- 361 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- Approval for design changes and a new supplier, Elbo Technics, for the RingJect.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.