PMA P900009S012
- Device
- EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S012
- Product code
- LPQ
- Decision date
- 2001-02-21
- 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 A CHANGE IN LABELING FOR THE EXOGEN 3000(R), TO INCORPORATE BOTH THE FRESH FRACTURE AND NONUNION INFORMATION INTO ONE SET OF PHYSICIAN'S INSTRUCTIONS FOR USE, PATIENT'S INSTRUCTIONS FOR USE, AND PRODUCT INSERT BULLETIN; TO MAKE MANUAL SIZE AND FORMATTING CHANGES, AND TO ADD NONUNION BACKGROUND INFORMATION.
Current openFDA PMA Record#
- Device
- EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S012
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 2001-02-21
- Decision code
- APPR
- Date received
- 2000-10-12
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR A CHANGE IN LABELING FOR THE EXOGEN 3000(R), TO INCORPORATE BOTH THE FRESH FRACTURE AND NONUNION INFORMATION INTO ONE SET OF PHYSICIAN'S INSTRUCTIONS FOR USE, PATIENT'S INSTRUCTIONS FOR USE, AND PRODUCT INSERT BULLETIN; TO MAKE MANUAL SIZE AND FORMATTING CHANGES, AND TO ADD NONUNION BACKGROUND INFORMATION.