BETA-CATH SYSTEM
FDA premarket approval P000018/S042 · decided 2006-06-16
Approval details
- PMA number
- P000018
- Supplement
- S042
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BETA-CATH SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Best Vascular, Inc.
- Date received
- 2006-03-09
- Decision date
- 2006-06-16
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Norcross, GA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE BETA-CATH SYSTEM LABELING, SPECIFICALLY THE INCORPORATION OF THE START/START 40/20 5-YEAR POST-APPROVAL STUDY RESULTS IN THE BETA-CATH INSTRUCTIONS FOR USE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.