PMA N16895S085

Device: SOFLENS (POLYMACON) CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: N16895
Supplement: S085
Product code: LPM
Decision date: 1997-10-15
Classification: Lenses, Soft Contact, Extended Wear
Generic name: Lenses, soft contact, extended wear
Approval order statement: Approval for labeling modifications: 1) combination of the separate package insert and professional fitting guide into a single package insert and fitting guide; and 2) incorporation of information in the package insert and fitting guide related to prescribing the lenses for frequent replacement and disposable wear, along with separate patient information booklets for disposable and frequent replacement wear.

Current openFDA PMA Record#

Device: SOFLENS (POLYMACON) CONTACT LENSES
Applicant: Bausch & Lomb, Inc.
PMA number: N16895
Supplement: S085
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 1997-10-15
Decision code: APPR
Date received: 1997-08-07
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for labeling modifications: 1) combination of the separate package insert and professional fitting guide into a single package insert and fitting guide; and 2) incorporation of information in the package insert and fitting guide related to prescribing the lenses for frequent replacement and disposable wear, along with separate patient information booklets for disposable and frequent replacement wear.