IMPLANTABLE MINIATURE TELESCOPE
FDA premarket approval P050034/S014 · decided 2014-09-12
Approval details
- PMA number
- P050034
- Supplement
- S014
- Supplement type
- Real-Time Process
- Trade name
- IMPLANTABLE MINIATURE TELESCOPE
- Generic name
- Telescope, implantable, miniature
- Applicant
- Samsara Vision, Inc.
- Date received
- 2014-06-11
- Decision date
- 2014-09-12
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Far Hills, NJ
- Statement
- MODIFICATION OF A PROCESS USED TO MANUFACTURE THE CATHETERS¿ QUAD LUMEN SOFT TIP.
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