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AURORA/QUANDRA,REFLEX,SIMPLEX AND META PACEMAKERS

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
St. Jude Medical, Inc.
Trade Name
AUTIMA(TM) MODEL 2251 & MODEL 2600
Generic Name
Implantable pulse generator, pacemaker (non-CRT)
Decision Date
2/10/1983
Days to Decision
317 days
Decision Code
APWD
FDA Decision
Withdrawal after approval

AURORA/QUANDRA,REFLEX,SIMPLEX AND META PACEMAKERS

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
St. Jude Medical, Inc.
Trade Name
AUTIMA(TM) MODEL 2251 & MODEL 2600
Generic Name
Implantable pulse generator, pacemaker (non-CRT)
Decision Date
2/10/1983
Days to Decision
317 days
Decision Code
APWD
FDA Decision
Withdrawal after approval