PMA P010059S001

Device: ALCON REFORM CAPSULAR TENSION RING
Applicant: Morcher GmbH
PMA number: P010059
Supplement: S001
Product code: MRJ
Decision date: 2004-03-15
Generic name: Ring, endocapsular
Approval order statement: APPROVAL FOR A PRIVATE LABEL DISTRIBUTOR AGREEMENT WITH ALCON LABORATORIES, INC., FORT WORTH, TEXAS. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME ALCON REFORM CAPSULAR TENSION RINGS (MODELS ACTR10, ACTR11, AND ACTR12).

Current openFDA PMA Record#

Device: ALCON REFORM CAPSULAR TENSION RING
Applicant: Morcher GmbH
PMA number: P010059
Supplement: S001
Product code: MRJ
Generic name: Ring, endocapsular
Decision date: 2004-03-15
Decision code: APPR
Date received: 2004-01-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A PRIVATE LABEL DISTRIBUTOR AGREEMENT WITH ALCON LABORATORIES, INC., FORT WORTH, TEXAS. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME ALCON REFORM CAPSULAR TENSION RINGS (MODELS ACTR10, ACTR11, AND ACTR12).