IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X
FDA premarket approval P050034/S006 · decided 2012-02-23
Approval details
- PMA number
- P050034
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMPLANTABLE MINIATURE TELESCOPE (IMT) MODES WIDE ANGLE 2.2X & WIDE ANGLE 2.7X
- Generic name
- Telescope, implantable, miniature
- Applicant
- Samsara Vision, Inc.
- Date received
- 2011-12-27
- Decision date
- 2012-02-23
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Far Hills, NJ
- Statement
- APPROVAL FOR THE ADDITION OF THE INFORMATION REGARDING THE SAFETY OF THE DEVICE DURING MRI EXPOSURE TO THE PATIENT INFORMATION BOOKLET.
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