MARGINPROBE SYSTEM
FDA premarket approval P110014/S002 · decided 2014-05-15
Approval details
- PMA number
- P110014
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MARGINPROBE SYSTEM
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2014-01-28
- Decision date
- 2014-05-15
- Days to decision
- 107 days
- Decision code
- APPR
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Business Park-South 3088900
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDIMOR LTD., IN TIBERIAS, ISRAEL (CONTRACT MANUFACTURER).
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