RINGJECT
FDA premarket approval P030023/S005 · decided 2016-07-06
Approval details
- PMA number
- P030023
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RINGJECT
- Generic name
- Ring, endocapsular
- Applicant
- Ophtec BV
- Date received
- 2016-06-10
- Decision date
- 2016-07-06
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- Modification of the current blunt finish distal tip on capsular tension ring (CTR) injector to an angular (beveled) distal tip finish.
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