iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
FDA premarket approval P170043/S001 · decided 2019-04-16
Approval details
- PMA number
- P170043
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2018-07-23
- Decision date
- 2019-04-16
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| iStent infinite Trabecular Micro-Bypass System, Model iS3 (K220032) | Glaukos Corporation | 2022-08-02 |