PMA P030016S032
- Device
- Visian Implantable Collamer Lens for Myopia
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S032
- Product code
- MTA
- Decision date
- 2017-07-20
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- Addition of an alternate manufacturing process at the Monrovia facility.
Current openFDA PMA Record#
- Device
- Visian Implantable Collamer Lens for Myopia
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S032
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2017-07-20
- Decision code
- OK30
- Date received
- 2017-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate manufacturing process at the Monrovia facility.