PMA P010012S264
- Device
- ACUITY SPIRAL LEAD
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S264
- Product code
- LWP
- Decision date
- 2011-04-07
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR REASSIGNMENT OF A MECHANICAL INPUT SPECIFICATION, SUTURE SLEEVE RESISTANCE TO CUT-THROUGH FROM THE SUTURE SLEEVE, TO THE LEAD BODY FOR THE ACUITY SPIRAL IMPLANTABLE LEAD.
Current openFDA PMA Record#
- Device
- ACUITY SPIRAL LEAD
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S264
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2011-04-07
- Decision code
- APPR
- Date received
- 2011-02-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REASSIGNMENT OF A MECHANICAL INPUT SPECIFICATION, SUTURE SLEEVE RESISTANCE TO CUT-THROUGH FROM THE SUTURE SLEEVE, TO THE LEAD BODY FOR THE ACUITY SPIRAL IMPLANTABLE LEAD.