PMA P030016S041
- Device
- Visian Implantable Collamer Lens (ICL)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S041
- Product code
- MTA
- Decision date
- 2021-07-19
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- Adding an alternative facility for water and pre-sterile product bioburden testing.
Current openFDA PMA Record#
- Device
- Visian Implantable Collamer Lens (ICL)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S041
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2021-07-19
- Decision code
- OK30
- Date received
- 2021-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding an alternative facility for water and pre-sterile product bioburden testing.