BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
FDA premarket approval P010062/S008 · decided 2014-07-28
Approval details
- PMA number
- P010062
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Bausch & Lomb
- Date received
- 2010-10-20
- Decision date
- 2014-07-28
- Days to decision
- 1377 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS).
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