CIONNI CAPSULAR TENSION RINGS
FDA premarket approval P010059/S002 · decided 2005-10-14
Approval details
- PMA number
- P010059
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CIONNI CAPSULAR TENSION RINGS
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2004-08-03
- Decision date
- 2005-10-14
- Days to decision
- 437 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Stuttgart
- Statement
- APPROVAL FOR THE MORCHER CIONNI CAPSULAR TENSION RINGS (TYPES 1L, 2L, AND 2C). 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
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