IMPLANTABLE MINIATURE TELESCOPE
FDA premarket approval P050034/S008 · decided 2013-01-22
Approval details
- PMA number
- P050034
- Supplement
- S008
- 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
- 2012-12-20
- Decision date
- 2013-01-22
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- NCJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Far Hills, NJ
- Statement
- MINOR CHANGES TO THE ROUTINE STERILIZATION PROCESS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.