PMA P010012S389
- Device
- DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA ICD'S
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S389
- Decision date
- 2015-06-22
- Approval order statement
- REMOVE A PROCESS MONITORING STEP DURING BATTERY ANODEMANUFACTURING FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA ICD'S
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S389
- Decision date
- 2015-06-22
- Decision code
- OK30
- Date received
- 2015-05-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVE A PROCESS MONITORING STEP DURING BATTERY ANODEMANUFACTURING FOR THE DEVICES.