BOSTON ORTHOKERATOLOGY SHAPING LENS FOR OVERNIGHT WEAR
FDA premarket approval P010062/S009 · decided 2011-06-22
Approval details
- PMA number
- P010062
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BOSTON ORTHOKERATOLOGY SHAPING LENS FOR OVERNIGHT WEAR
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- Bausch & Lomb
- Date received
- 2011-05-31
- Decision date
- 2011-06-22
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- ALTERNATE SUPPLIER OF 0.2 MICRON FORMULATION FILTER.
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