PMA P010012S354
- Device
- DYNAGEN,INOGEN,ORIGEN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S354
- Product code
- LWP
- Decision date
- 2014-05-23
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADDITION OF A SECOND PULSE GENERATOR (PG) DEVICE HEADER OVERMOLDING MAIN LINE 2 AT THE CLONMEL MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- DYNAGEN,INOGEN,ORIGEN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S354
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-05-23
- Decision code
- OK30
- Date received
- 2014-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SECOND PULSE GENERATOR (PG) DEVICE HEADER OVERMOLDING MAIN LINE 2 AT THE CLONMEL MANUFACTURING FACILITY.