PMA P090013S155
- Device
- CAPSUREFIX MRI LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S155
- Product code
- LWP
- Decision date
- 2014-09-24
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- INCREASE IN THE STAGING DURATION FOR THE SLEEVEHEADS, COUPLERS, AND RETAINERS AND FOR THE USAGE OF AN UNHEATED HEPTANE BATH INSTEAD OF A HEATED HEPTANE BATH.
Current openFDA PMA Record#
- Device
- CAPSUREFIX MRI LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S155
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-09-24
- Decision code
- OK30
- Date received
- 2014-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INCREASE IN THE STAGING DURATION FOR THE SLEEVEHEADS, COUPLERS, AND RETAINERS AND FOR THE USAGE OF AN UNHEATED HEPTANE BATH INSTEAD OF A HEATED HEPTANE BATH.