PMA P910077S148
- Device
- LATITUDE CONSULT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S148
- Product code
- OSR
- Decision date
- 2015-01-06
- Classification
- Pacemaker/icd/crt Non-implanted Components
- Generic name
- Pacemaker/icd/crt non-implanted components
- Approval order statement
- APPROVAL FOR THE ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.
Current openFDA PMA Record#
- Device
- LATITUDE CONSULT SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S148
- Product code
- OSR
- Generic name
- Pacemaker/icd/crt non-implanted components
- Decision date
- 2015-01-06
- Decision code
- APPR
- Date received
- 2014-11-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF SUPPORT FOR THE INGENIO 2 FAMILY OF IMPLANTABLE DEVICES TO THE LATITUDE CONSULT SYSTEM VERSION 1.01.