LIPOSORBER LA-15 SYSTEM
FDA premarket approval P910018/S002 · decided 2002-04-09
Approval details
- PMA number
- P910018
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- LIPOSORBER LA-15 SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 1998-12-15
- Decision date
- 2002-04-09
- Days to decision
- 1211 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR MODIFICATIONS TO THE PATIENT REGISTRY/POST-MARKET STUDY OF THE LIPOSORBER. LA-15 SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.