PMA P900009S002
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S002
- Product code
- LPQ
- Decision date
- 1996-04-02
- 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 NEW MANUFACTURING FACILITY WHICH IS OWNED AND OPERATED BY HI-TRONICS DESIGNS, INC. AND LOCATED AT 999 WILLOW GROVE ST., BUILDING 2, SUITES 4A, 4B AND 18E, HACKETTSTOWN, NJ 07840. THE SAFHS MODEL 2A WILL BE MANUFACTURED AT THIS SITE
Current openFDA PMA Record#
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S002
- Product code
- LPQ
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Decision date
- 1996-04-02
- Decision code
- APPR
- Date received
- 1995-12-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY WHICH IS OWNED AND OPERATED BY HI-TRONICS DESIGNS, INC. AND LOCATED AT 999 WILLOW GROVE ST., BUILDING 2, SUITES 4A, 4B AND 18E, HACKETTSTOWN, NJ 07840. THE SAFHS MODEL 2A WILL BE MANUFACTURED AT THIS SITE