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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 3-63: ISO 11318:2002, cardiac defibrillators -- connector assembly df-1 for implantable defibrillators - dimensions and test requirements. (Cardiovascular)

Date of Standard: 2002. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Implantable Cardioverter Defibrillators
Processes Affected:
PMA, IDE, PDP
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
Unclassified Defibrillator, Implantable, Dual-Chamber Class 3 MRM
Unclassified Implantable Cardioverter Defibrillator (Non-Crt) Class 3 LWS
Relevant Guidance:
Guidance for Industry and FDA Reviewers on Implantable Cardioverter Defibrillators (Draft 4.8, April 16, 1999)
FDA Technical Contact:
 Mitchell J. Shein
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1316
  Silver Spring MD 20993
  301/796-6363
  email: mitchell.shein@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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