PMA P090013S185
- Device
- CAPSUREFIX MRI LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S185
- Product code
- LWP
- Decision date
- 2015-05-14
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- UPDATED BIOBURDEN TEST METHODS FOR THE IMPLANTABLE PULSE GENERATOR AND LEAD MODELS FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- CAPSUREFIX MRI LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S185
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2015-05-14
- Decision code
- OK30
- Date received
- 2015-04-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATED BIOBURDEN TEST METHODS FOR THE IMPLANTABLE PULSE GENERATOR AND LEAD MODELS FOR THE DEVICES.