PMA P960028S002

Device: AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P960028
Supplement: S002
Product code: MFK
Decision date: 1997-12-30
Generic name: Lens, multifocal intraocular
Approval order statement: Approval for the addition of an alternate manufacturing site, A.M.O. Puerto Rico, Inc., and an alternate sterilization site, Steri-Tech, Inc.

Current openFDA PMA Record#

Device: AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P960028
Supplement: S002
Product code: MFK
Generic name: Lens, multifocal intraocular
Decision date: 1997-12-30
Decision code: APPR
Date received: 1997-10-24
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of an alternate manufacturing site, A.M.O. Puerto Rico, Inc., and an alternate sterilization site, Steri-Tech, Inc.