MARGINPROBE SYSTEM
FDA premarket approval P110014/S004 · decided 2014-10-22
Approval details
- PMA number
- P110014
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MARGINPROBE SYSTEM
- Generic name
- Diagnostic low electric field
- Applicant
- Dilon Medical Technologies, Ltd.
- Date received
- 2014-09-23
- Decision date
- 2014-10-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OEE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Business Park-South 3088900
- Statement
- ADDITION OF A TEST JIG AND THE REPLACEMENT OF THE VACUUM PRESSURE REGULATOR COMPONENT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.