ACRYSOR SINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL SA60AT ECTEDED DIOPTER RANGE
FDA premarket approval P930014/S010 · decided 2002-10-07
Approval details
- PMA number
- P930014
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACRYSOR SINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL SA60AT ECTEDED DIOPTER RANGE
- Generic name
- intraocular lens
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2002-09-11
- Decision date
- 2002-10-07
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL TO EXTEND THE MODEL SA60AT POWER RANGE FROM +6.0D THROUGH +34.0D TO +6.0 THROUGH +40.0D.
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