PMA P010012S006
- Device
- CONTAK CD/EASYTRAK LEADS & ACCESSORIES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S006
- Product code
- NIK
- Decision date
- 2002-12-13
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
Current openFDA PMA Record#
- Device
- CONTAK CD/EASYTRAK LEADS & ACCESSORIES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S006
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2002-12-13
- Decision code
- OK30
- Date received
- 2002-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.