HEALON DUET DUAL PACK
FDA premarket approval P810031/S059 · decided 2017-10-31
Approval details
- PMA number
- P810031
- Supplement
- S059
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEALON DUET DUAL PACK
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2016-11-14
- Decision date
- 2017-10-31
- Days to decision
- 351 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for a manufacturing site located at Lifecore Biomedical, LLC, 1245 Lakeview Drive Chaska, Minnesota to be used for post-sterilization final packaging,warehousing, and distribution activities.
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510(k) clearances by this applicant
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| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
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| UNFOLDER Vitan Inserter (K191949) | Johnson & Johnson Surgical Vision, Inc. | 2019-09-13 |
| COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal (K191933) | Johnson & Johnson Surgical Vision, Inc. | 2019-08-16 |