EYEJET INJECTOR
FDA premarket approval P010059/S004 · decided 2013-05-23
Approval details
- PMA number
- P010059
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EYEJET INJECTOR
- Generic name
- Ring, endocapsular
- Applicant
- Morcher GmbH
- Date received
- 2011-11-08
- Decision date
- 2013-05-23
- Days to decision
- 562 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Stuttgart
- Statement
- APPROVAL FOR THE EXPANSION OF YOUR FAMILY OF CAPSULAR TENSION RINGS (CTRS) AVAILABLE PRE-LOADED ON THE EYEJET INJECTOR TO INCLUDE NEW CTR MODELS TYPE 10G, 10L, 15, 15A, AND 15B. IN ADDITION, YOU REQUESTED APPROVAL TO SUPPLY CURRENTLY APPROVED CTR TYPE 10C AS PRE-LOADED ON THE EYEJET INJECTOR.
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