PMA P010012S351
- Device
- INVIVE AND INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S351
- Product code
- LWP
- Decision date
- 2014-05-12
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADDING AN ALTERNATE OSCILLATOR CRYSTAL COMPONENT TO HYBRID BILL OF MATERIALS FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- INVIVE AND INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S351
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-05-12
- Decision code
- OK30
- Date received
- 2014-04-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDING AN ALTERNATE OSCILLATOR CRYSTAL COMPONENT TO HYBRID BILL OF MATERIALS FOR THE DEVICES.