PMA P970034S001

Device: UV ABSORBING-PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant: Aaren Scientific
PMA number: P970034
Supplement: S001
Product code: HQL
Decision date: 1998-11-20
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: The 30-day Notice requested approval to introduce a manufacturing process change for the device. The nature of the change is to use an alternate sterilization chambera t Griffith MicroScience, the same sterilization contractor approved in the firm's original PMA. Griffith is upgrading the chamber that was previously used. Some of the parameters of the sterilization process are being changed. The changes include reduction of the minimum preconditioning time, specification of the transfer time to move the load from the preconditioning room into the sterilization chamber, use of a larger sterilization chamber, use of a computer-controlled process versus a manually-controlled process and the addition of post-ethylene oxide exposure vacuum dwell times.

Current openFDA PMA Record#

Device: UV ABSORBING-PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant: Aaren Scientific
PMA number: P970034
Supplement: S001
Product code: HQL
Generic name: intraocular lens
Decision date: 1998-11-20
Decision code: OK30
Date received: 1998-10-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-day Notice requested approval to introduce a manufacturing process change for the device. The nature of the change is to use an alternate sterilization chambera t Griffith MicroScience, the same sterilization contractor approved in the firm's original PMA. Griffith is upgrading the chamber that was previously used. Some of the parameters of the sterilization process are being changed. The changes include reduction of the minimum preconditioning time, specification of the transfer time to move the load from the preconditioning room into the sterilization chamber, use of a larger sterilization chamber, use of a computer-controlled process versus a manually-controlled process and the addition of post-ethylene oxide exposure vacuum dwell times.