Implantable Miniature Telescope
FDA premarket approval P050034/S019 · decided 2017-10-20
Approval details
- PMA number
- P050034
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Implantable Miniature Telescope
- Generic name
- Telescope, implantable, miniature
- Applicant
- Samsara Vision, Inc.
- Date received
- 2017-09-21
- Decision date
- 2017-10-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Far Hills, NJ
- Statement
- Alternate supplier for a component of the telescope sub-assembly for Models Wide Angle 2.2X and Wide Angle 2.7X.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.