IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
FDA premarket approval P050034/S009 · decided 2013-11-05
Approval details
- PMA number
- P050034
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- IMPLANTABLE MINIATURE TELESCOPE (IMT) MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X
- Generic name
- Telescope, implantable, miniature
- Applicant
- Samsara Vision, Inc.
- Date received
- 2013-05-15
- Decision date
- 2013-11-05
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Far Hills, NJ
- Statement
- APPROVAL FOR MODIFICATIONS TO THE APPROVED PROFESSIONAL USE INFORMATION AND PATIENT INFORMATION BOOKLET TO ADD INFORMATION OBTAINED FROM POST-APPROVAL STUDY IMT-002-LTME.
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