Atlas FDA

MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM

FDA premarket approval P900061 · decided 1993-02-11

Approval details

PMA number
P900061
Trade name
MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM
Generic name
Implantable cardioverter defibrillator (non-CRT)
Applicant
Medtronic Cardiac Rhythm Disease Management
Date received
1990-09-28
Decision date
1993-02-11
Days to decision
867 days
Decision code
APPR
Product code
LWS
Advisory committee
Cardiovascular
Expedited review
No
Location
Mounds View, MN

Class III intelligence, same tools

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