IMPLANTABLE MINIATURE TELESCOPE
FDA premarket approval P050034/S004 · decided 2011-02-04
Approval details
- PMA number
- P050034
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- IMPLANTABLE MINIATURE TELESCOPE
- Generic name
- Telescope, implantable, miniature
- Applicant
- Samsara Vision, Inc.
- Date received
- 2010-12-15
- Decision date
- 2011-02-04
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Far Hills, NJ
- Statement
- APPROVAL FOR EXTENDING THE SHELF LIFE OF THE IMT FROM 2 YEARS TO 3 YEARS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.