PMA P010012S388
- Device
- DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S388
- Decision date
- 2015-06-04
- Approval order statement
- ENHANCEMENT OF THE IS-1 AND IS-4 COIL SPRING INSPECTIONS AT THE SUPPLIER BY ADDING AN AUTOMATED VISION (AVI) SYSTEM.
Current openFDA PMA Record#
- Device
- DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S388
- Decision date
- 2015-06-04
- Decision code
- OK30
- Date received
- 2015-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ENHANCEMENT OF THE IS-1 AND IS-4 COIL SPRING INSPECTIONS AT THE SUPPLIER BY ADDING AN AUTOMATED VISION (AVI) SYSTEM.