PMA P010012S330
- Device
- CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS, INC EPTA, ENERGEN, PUNCTUA, C OGNIS CRT-D'S
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S330
- Product code
- LWP
- Decision date
- 2013-06-21
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADDITION OF TWO NEW MOSFET ACCEPTANCE TEST CASES FOR THE ABOVE REFERENCEDDEVICES.
Current openFDA PMA Record#
- Device
- CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS, INC EPTA, ENERGEN, PUNCTUA, C OGNIS CRT-D'S
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S330
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-06-21
- Decision code
- OK30
- Date received
- 2013-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF TWO NEW MOSFET ACCEPTANCE TEST CASES FOR THE ABOVE REFERENCEDDEVICES.