Supplemental Data Sheet FDA-3427 PSC/HHS

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Specifications	Supplemental Data Sheet FDA-3427 PSC/HHS
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FORM FDA 3427 (1/09)PSC Graphics (301) 443-1090 FORM APPROVED: OMB NO. 0910-0138 EXPIRATION DATE: March 31, 2009 (See OMB Sta

Specifications	Supplemental Data Sheet FDA-3427 PSC/HHS
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Content	FORM FDA 3427 (1/09)PSC Graphics (301) 443-1090 FORM APPROVED: OMB NO. 0910-0138 EXPIRATION DATE: March 31, 2009 (See OMB Statement on Page 2) Classification DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION 1. GENERIC TYPE OF DEVICE No 2. ADVISORY PANEL 4. INDICATIONS FOR USE IN THE DEVICE’S LABELING 3. IS DEVICE AN IMPLANT (21 CFR 860.3)? Yes 5. IDENTIFICATION OF ANY RISKS TO HEALTH PRESENTED BY DEVICE General 6. RECOMMENDED ADVISORY PANEL CLASSIFICATION AND PRIORITY Priority (Class II or III Only) 7. IF DEVICE IS AN IMPLANT, OR IS LIFE-SUSTAINING OR LIFE-SUPPORTING AND HAS BEEN CLASSIFIED IN A CATEGORY OTHER THAN CLASS III, EXPLAIN FULLY, THE REASONS FOR THE LOWER CLASSIFICATION WITH SUPPORTING DOCUMENTATION AND DATA 8. SUMMARY OF INFORMATION, INCLUDING CLINICAL EXPERIENCE OR JUDGMENT, UPON WHICH CLASSIFICATION RECOMMENDATION IS BASED 9. IDENTIFICATION OF ANY NEEDED RESTRICTIONS ON THE USE OF THE DEVICE (e.g., special labeling, banning, or prescription use) Panel Recommendation Page 1EF SUPPLEMENTAL DATA SHEET
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