BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR
FDA premarket approval P850022/S013 · decided 2001-10-10
Approval details
- PMA number
- P850022
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Ahp Eos Buyer, Inc.
- Date received
- 2001-06-11
- Decision date
- 2001-10-10
- Days to decision
- 121 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Parsippany, NJ
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY LOCATED AT ELECTRO-BIOLOGY, INC., GUAYNABO, PUERTO RICO.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.