PMA P010012S130
- Device
- PRIZM AND VITALITY FAMILIES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S130
- Product code
- LWP
- Decision date
- 2006-08-08
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR & SOFTWARE V1.2.0 AND REGULATED APPLICATION SERVER (RAS) V2.0.3.
Current openFDA PMA Record#
- Device
- PRIZM AND VITALITY FAMILIES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S130
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2006-08-08
- Decision code
- APPR
- Date received
- 2006-05-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- LATITUDE PATIENT MANAGEMENT SYSTEM MODEL 6481 INDUCTIVE COMMUNICATOR & SOFTWARE V1.2.0 AND REGULATED APPLICATION SERVER (RAS) V2.0.3.