HORIZON(TM) YAG LASER MODEL 2000
FDA premarket approval P850001/S006 · decided 1986-12-01
Approval details
- PMA number
- P850001
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HORIZON(TM) YAG LASER MODEL 2000
- Generic name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Applicant
- CooperVision, Inc.
- Date received
- 1986-09-15
- Decision date
- 1986-12-01
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San German, PR
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