ALCON REFORM CAPSULAR TENSION RING
FDA premarket approval P010059/S001 · decided 2004-03-15
Approval details
- PMA number
- P010059
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ALCON REFORM CAPSULAR TENSION RING
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2004-01-20
- Decision date
- 2004-03-15
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Stuttgart
- 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).
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