BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR
FDA premarket approval P850022/S025 · decided 2015-09-09
Approval details
- PMA number
- P850022
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2015-08-10
- Decision date
- 2015-09-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- QUALIFY TWO ALTERNATE SUPPLIERS FOR THE SOFT-TOUCH® HYDROGEL DISPOSABLE, CUTANEOUS ELECTRODES AND TO REINSTATE THE SOFT-TOUCH 63B HYDROGEL BASED, DISPOSABLE, CUTANEOUS ELECTRODE USED IN CONJUNCTION WITH THE BIOMET® ORTHOPAK® NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM AND SPINALPAK® NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM.
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