PMA P940016S004
- Device
- HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM
- Applicant
- B. Braun Avitum AG
- PMA number
- P940016
- Supplement
- S004
- Product code
- MMY
- Decision date
- 1999-08-12
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- Approval for administering the SF-36 quality of life (QOL) survey on an annual basis, instead of on a quarterly basis, of rthe patient registry/post approval study of the H.E.L.P. System.
Current openFDA PMA Record#
- Device
- HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM
- Applicant
- B. Braun Avitum AG
- PMA number
- P940016
- Supplement
- S004
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 1999-08-12
- Decision code
- APPR
- Date received
- 1998-12-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for administering the SF-36 quality of life (QOL) survey on an annual basis, instead of on a quarterly basis, of rthe patient registry/post approval study of the H.E.L.P. System.