MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C
FDA premarket approval P010059 · decided 2003-10-23
Approval details
- PMA number
- P010059
- Trade name
- MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2001-10-16
- Decision date
- 2003-10-23
- Days to decision
- 737 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Stuttgart
- Statement
- APPROVAL FOR THE MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14C. THE DEVICE IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK OR PARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION. CONDITIONS ASSOCIATED WITH WEAK OR PARTIALLY ABSENT ZONULES MAY INCLUDE PRIMARY ZONULAR WEAKNESS (E.G., MARFAN'S SYNDROME), SECONDARY ZONULAR WEAKNESS (E.G., TRAUMA OR VITRECTOMY) CASES OF ZONULYSIS, CASES OF PSEUD
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