PMA P030016S031
- Device
- Visian Implantable Collamer Lens for Myopia
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S031
- Product code
- MTA
- Decision date
- 2017-06-16
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- Adding an alternative water purification system to the STARR Surgical Monrovia, CA manufacturing site.
Current openFDA PMA Record#
- Device
- Visian Implantable Collamer Lens for Myopia
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S031
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2017-06-16
- Decision code
- OK30
- Date received
- 2017-05-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an alternative water purification system to the STARR Surgical Monrovia, CA manufacturing site.