ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
FDA premarket approval P080030/S013 · decided 2015-08-07
Approval details
- PMA number
- P080030
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2015-02-09
- Decision date
- 2015-08-07
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Laguna Hills, CA
- Statement
- APPROVAL TO UPDATE YOUR LABELING TO INCLUDE THE RESULTS OF YOUR POST-APPROVAL STUDY (PAS) FOR THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM, EXTENDED FOLLOW-UP OF THE INVESTIGATIONAL DEVICE EXEMPTION (IDE) COHORT STUDY.
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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 |