PMA P010012S316
- Device
- COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, ENERGEN
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S316
- Product code
- LWP
- Decision date
- 2012-12-11
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADD A NEW OFF-THE-SHELF LASER WELDER FOR USE IN THE BATTERY MANUFACTURING.
Current openFDA PMA Record#
- Device
- COGNIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, ENERGEN
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S316
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2012-12-11
- Decision code
- OK30
- Date received
- 2012-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A NEW OFF-THE-SHELF LASER WELDER FOR USE IN THE BATTERY MANUFACTURING.