PMA P010012S160
- Device
- ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S160
- Product code
- LWP
- Decision date
- 2008-05-16
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE ACUITY SPIRAL LEAD MODEL 4591, 4592, AND 4593. THE DEVICE IS INDICATED FOR CHRONIC, LEFT-VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR.
Current openFDA PMA Record#
- Device
- ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S160
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2008-05-16
- Decision code
- APPR
- Date received
- 2007-10-09
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR THE ACUITY SPIRAL LEAD MODEL 4591, 4592, AND 4593. THE DEVICE IS INDICATED FOR CHRONIC, LEFT-VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE PULSE GENERATOR.