ARTISAN/VERISYSE PHAKIC IOL
FDA premarket approval P030028/S001 · decided 2011-11-09
Approval details
- PMA number
- P030028
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- ARTISAN/VERISYSE PHAKIC IOL
- Generic name
- Lens, intraocular, phakic
- Applicant
- Ophtec BV
- Date received
- 2009-11-25
- Decision date
- 2011-11-09
- Days to decision
- 714 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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