PMA N16895S086

Device: BAUSCH AND LOMB POLYMACON CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: N16895
Supplement: S086
Product code: LPM
Decision date: 1999-11-02
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: The 30-Day Notice requested introduction of a manufacturing process change for the Polymacon Contact Lenses for extended wear. The requested change will allow the lenses to be manufactured using an alternate polyvinyl chloride resin mold material. The manufacturing process and procedures will not change.

Current openFDA PMA Record#

Device: BAUSCH AND LOMB POLYMACON CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: N16895
Supplement: S086
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1999-11-02
Decision code: OK30
Date received: 1999-10-26
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 for the Polymacon Contact Lenses for extended wear. The requested change will allow the lenses to be manufactured using an alternate polyvinyl chloride resin mold material. The manufacturing process and procedures will not change.