GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
FDA premarket approval P080030/S002 · decided 2012-11-08
Approval details
- PMA number
- P080030
- Supplement
- S002
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Glaukos Corporation
- Date received
- 2012-07-09
- Decision date
- 2012-11-08
- Days to decision
- 122 days
- Decision code
- APPR
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Laguna Hills, CA
- Statement
- MODIFICATIONS TO THE DESIGN OF THE OUTER BLISTER TRAY USED FOR DEVICE PACKAGING.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| iStent infinite Trabecular Micro-Bypass System, Model iS3 (K220032) | Glaukos Corporation | 2022-08-02 |