CyPass System, CyPass Ultra System, CyPass Micro-Stent
FDA premarket approval P150037/S011 · decided 2018-08-13
Approval details
- PMA number
- P150037
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CyPass System, CyPass Ultra System, CyPass Micro-Stent
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Alcon Research, Ltd.
- Date received
- 2018-07-16
- Decision date
- 2018-08-13
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Addition of an alternate additional vendor for the laser cutting step in the manufacturing process of the CyPass System Model 241-S and the CyPass Ultra System.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CENTURION Vision System (Active SentryTM) (K161794) | Alcon Research, Ltd. | 2017-04-14 |
| HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (K170520) | Alcon Research, Ltd. | 2017-03-22 |
| CONSTELLATION VISION SYSTEM (K141065) | Alcon Research, Ltd. | 2014-08-22 |
| WAVELIGHT FS200 PATIENT INTERFACE 1505 (K121031) | Alcon Research, Ltd. | 2012-06-21 |
| MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) (K112977) | Alcon Research, Ltd. | 2012-03-27 |
| 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA (K110951) | Alcon Research, Ltd. | 2011-10-17 |
| CLEARCUT S SAFETY KNIFE (K110166) | Alcon Research, Ltd. | 2011-05-20 |
| ALCON MULTI-PIRPOSE DISINFECTING SOLUTION (K102860) | Alcon Research, Ltd. | 2011-05-10 |