BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM
FDA premarket approval P850022/S022 · decided 2014-05-09
Approval details
- PMA number
- P850022
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Trade name
- BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR SYSTEM
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2014-04-10
- Decision date
- 2014-05-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- ADDITION OF NEW LABELING EQUIPMENT.
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