PMA P010012S026
- Device
- CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 AND H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, A
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S026
- Product code
- NIK
- Decision date
- 2004-09-14
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR THE CONTAK CD, CONTAK CD 2, RENEWAL, AND RENEWAL 3 DEVICES. THESE DEVICES ARE INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P010012S026B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- CONTAK CD (MODEL 1823), CONTAK CD 2 (MODELS H115 AND H119), RENEWAL (MODEL H135), RENEWAL 3 (MODELS H170, H175, H177, A
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S026
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2004-09-14
- Decision code
- APPR
- Date received
- 2004-03-29
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE CONTAK CD, CONTAK CD 2, RENEWAL, AND RENEWAL 3 DEVICES. THESE DEVICES ARE INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF = 120 MS.