PMA P010012S297
- Device
- COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S297
- Product code
- LWP
- Decision date
- 2012-08-22
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADD AN AUTOMATIC OPTICAL INSPECTION (AOI) SYSTEM USED TO INSPECT COMPONENT PLACED ON THE PRINTED CIRCUIT BOARD.
Current openFDA PMA Record#
- Device
- COGNIS, INCEPTA, ENERGEN AND PUNCTUA CRT-D DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S297
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2012-08-22
- Decision code
- OK30
- Date received
- 2012-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD AN AUTOMATIC OPTICAL INSPECTION (AOI) SYSTEM USED TO INSPECT COMPONENT PLACED ON THE PRINTED CIRCUIT BOARD.