PMA P030005S029
- Device
- CONTAK RENEWAL
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S029
- Product code
- NKE
- Decision date
- 2006-05-05
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- CHANGE FROM A MANUAL TO AN AUTOMATED INSPECTION OF THE SOLDER BALLS ON BALL GRID ARRAY MODULES.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL
- Applicant
- Guidant Corp.
- PMA number
- P030005
- Supplement
- S029
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2006-05-05
- Decision code
- APPR
- Date received
- 2005-12-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FROM A MANUAL TO AN AUTOMATED INSPECTION OF THE SOLDER BALLS ON BALL GRID ARRAY MODULES.