SENSAR SOFT ACRYLIC UV LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
FDA premarket approval P980040/S006 · decided 2005-02-04
Approval details
- PMA number
- P980040
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SENSAR SOFT ACRYLIC UV LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2005-01-03
- Decision date
- 2005-02-04
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO MODIFY THE "INDICATIONS" STATEMENTS FOR ALL LEGALLY MARKETED IOLS UNDER THE ABOVE REFERENCED PMAS TO REFLECT ADULTS AS OPPOSED TO ADULTS OLDER THAN 60 YEARS OF AGE.
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