ACRYSOF RESTOR INTRAOCULAR LENS
FDA premarket approval P040020/S048 · decided 2014-04-28
Approval details
- PMA number
- P040020
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACRYSOF RESTOR INTRAOCULAR LENS
- Generic name
- Lens, multifocal intraocular
- Applicant
- Alcon Research, Ltd.
- Date received
- 2013-07-31
- Decision date
- 2014-04-28
- Days to decision
- 271 days
- Decision code
- APPR
- Product code
- MFK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THREE ALTERNATE POLYPROPYLENE MATERIALS, BASELL PD702, EXXON ACHIEVE 1605, AND EXXON PP1105E1, FOR INTRAOCULAR LENS (IOL) DEVICE PRIMARY PACKAGING.
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|---|---|---|
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| 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 |