Atlas FDA

TELECTRONICS OSTEOSTIM BONW GROWTH STIMULATOR MODE

FDA premarket approval P790005/S004 · decided 1981-02-03

Approval details

PMA number
P790005
Supplement
S004
Supplement type
Normal 180 Day Track
Trade name
TELECTRONICS OSTEOSTIM BONW GROWTH STIMULATOR MODE
Generic name
Stimulator, invasive bone growth
Applicant
Ahp Eos Buyer, Inc.
Date received
1980-12-16
Decision date
1981-02-03
Days to decision
49 days
Decision code
APPR
Product code
LOE
Advisory committee
Orthopedic
Expedited review
No
Location
Parsippany, NJ

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.