PMA P090013S073
- Device
- CAPSUREFIX MRI SURESCAN LEAD, 5086MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S073
- Product code
- LWP
- Decision date
- 2012-10-04
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SINGAPORE OPERATION PTE, IN SINGAPORE..
Current openFDA PMA Record#
- Device
- CAPSUREFIX MRI SURESCAN LEAD, 5086MRI
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S073
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2012-10-04
- Decision code
- APPR
- Date received
- 2012-08-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SINGAPORE OPERATION PTE, IN SINGAPORE..