PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212
FDA premarket approval P850007/S027 · decided 2005-04-05
Approval details
- PMA number
- P850007
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2003-06-04
- Decision date
- 2005-04-05
- Days to decision
- 671 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- APPROVAL TO MODIFY THE PHYSIO-STIM LITE, MODELS 202L, 303L, 215L, 313L, 314L AND SPINAL-STIM MODELS 212L AND 212LE AS FOLLOWS: 1) CHANGE THE POWER SOURCE FROM A 9-VOLT DISPOSABLE BATTERY TO AN 11.1-VOLT RECHARGEABLE; 2) CHANGE THE USER INTERFACE FROM A THREE COLOR LED TO A BACKLIT LCD DISPLAY; 3) CHANGE THE CIRCUIT ASSEMBLY FROM SEPARATE BOARDS FOR THE DRIVE CIRCUIT AND MICROCONTROLLER TO A SINGLE BOARD; 4) ADD AN OPTIONAL PERSONAL DATA ASSISTANT (PDA) THAT MAY BE USED TO SET DAILY SHUTDOWN TIME
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