PMA P820049S064
- Device
- MODELS PC-58NBM & PC-58NBZ IOLS
- Applicant
- Advanced Medical Optics, Inc.
- PMA number
- P820049
- Supplement
- S064
- Product code
- HQL
- Decision date
- 1997-10-02
- Classification
- Intraocular Lens
- Generic name
- intraocular lens
- Approval order statement
- Approval for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salina, Puerto Rico.
Current openFDA PMA Record#
- Device
- MODELS PC-58NBM & PC-58NBZ IOLS
- Applicant
- Advanced Medical Optics, Inc.
- PMA number
- P820049
- Supplement
- S064
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 1997-10-02
- Decision code
- APPR
- Date received
- 1997-06-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salina, Puerto Rico.