PMA P970034S004

Device: POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant: Aaren Scientific
PMA number: P970034
Supplement: S004
Product code: HQL
Decision date: 2000-04-28
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Approval for Allergan Surgical to distribute the Models RS-50B, RS-55B, RS-60B, RS-65, SP-60A, and SP-65A2 ultraviolet-absorbing posterior chamber intraocular lenses as Allergan's Duralens Models 52, 53, 54, 59, 60, and 65T, respectively.

Current openFDA PMA Record#

Device: POSTERIOR CHAMBER INTRAOCULAR LENSES
Applicant: Aaren Scientific
PMA number: P970034
Supplement: S004
Product code: HQL
Generic name: intraocular lens
Decision date: 2000-04-28
Decision code: APPR
Date received: 2000-02-14
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for Allergan Surgical to distribute the Models RS-50B, RS-55B, RS-60B, RS-65, SP-60A, and SP-65A2 ultraviolet-absorbing posterior chamber intraocular lenses as Allergan's Duralens Models 52, 53, 54, 59, 60, and 65T, respectively.