PMA P900009S030
- Device
- EXOGEN 4000+ BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S030
- Product code
- LPQ
- Decision date
- 2009-03-13
- Classification
- Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Approval order statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE MANUFACTURING OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA).
Current openFDA PMA Record#
- Device
- EXOGEN 4000+ BONE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S030
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2009-03-13
- Decision code
- APPR
- Date received
- 2008-12-23
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE MANUFACTURING OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA).