VISIONCARE IMPLANTABLE MINIATURE TELESCOPE
FDA premarket approval P050034/S015 · decided 2015-01-27
Approval details
- PMA number
- P050034
- Supplement
- S015
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- VISIONCARE IMPLANTABLE MINIATURE TELESCOPE
- Generic name
- Telescope, implantable, miniature
- Applicant
- Samsara Vision, Inc.
- Date received
- 2014-11-28
- Decision date
- 2015-01-27
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Far Hills, NJ
- Statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY PROTOCOL: UPDATED STUDY PROTOCOL WITH THE INCLUSION OF CASE REPORT FORM (CRF) AND STUDY TIMELINE.
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