PMA P910018S002
- Device
- LIPOSORBER LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S002
- Product code
- MMY
- Decision date
- 2002-04-09
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE PATIENT REGISTRY/POST-MARKET STUDY OF THE LIPOSORBER. LA-15 SYSTEM.
Current openFDA PMA Record#
- Device
- LIPOSORBER LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S002
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2002-04-09
- Decision code
- APPR
- Date received
- 1998-12-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE PATIENT REGISTRY/POST-MARKET STUDY OF THE LIPOSORBER. LA-15 SYSTEM.