MORCHER CAPSULAR TENSION RINGS
FDA premarket approval P010059/S003 · decided 2009-05-22
Approval details
- PMA number
- P010059
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MORCHER CAPSULAR TENSION RINGS
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2007-03-19
- Decision date
- 2009-05-22
- Days to decision
- 795 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Stuttgart
- Statement
- APPROVAL FOR THE ADDITION OF CAPSULAR TENSION RINGS (CTRS) MODELS1G, 2S, 6D, 6E, AND 10C AND CHANGE IN PACKAGING TO INCORPORATE THE MORCHER INJECTOR PRELOADED WITH CTR MODELS 14, 14A, AND 14C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MORCHER CAPSULAR TENSION RINGS (MODELS 1G, 2S, 6D, 6E, AND 10C) AND EYEJET CTR AND IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK ORPARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRA
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