PMA P970034S003

Device: UV-PMMA PCL'S
Applicant: Aaren Scientific
PMA number: P970034
Supplement: S003
Product code: HQL
Decision date: 1999-04-16
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: The 30-day Notice requested introduction of a manufacturing process change to use an alternate sterilization chamber (chamber #1) at Griffith MicroScience, the same sterilization contractor approved in the original PMA. Griffith is upgrading the chamber that was previously used. The proposed cycle is nearly identical to the currently-approved cycle for chamber #8, both chambers will use the computer-controlled process; the primary differences are that the chamber is smaller and an additional air wash with vacuum hold have beed added after the gas-dwell phase.

Current openFDA PMA Record#

Device: UV-PMMA PCL'S
Applicant: Aaren Scientific
PMA number: P970034
Supplement: S003
Product code: HQL
Generic name: intraocular lens
Decision date: 1999-04-16
Decision code: OK30
Date received: 1999-03-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-day Notice requested introduction of a manufacturing process change to use an alternate sterilization chamber (chamber #1) at Griffith MicroScience, the same sterilization contractor approved in the original PMA. Griffith is upgrading the chamber that was previously used. The proposed cycle is nearly identical to the currently-approved cycle for chamber #8, both chambers will use the computer-controlled process; the primary differences are that the chamber is smaller and an additional air wash with vacuum hold have beed added after the gas-dwell phase.