HORIZON(TM) YAG LASER MODEL 2000
FDA premarket approval P850001/S007 · decided 1987-04-20
Approval details
- PMA number
- P850001
- Supplement
- S007
- 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
- 1986-09-16
- Decision date
- 1987-04-20
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- LOI
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San German, PR
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.