PMA P980035S087
- Device
- ENRHYTHM IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S087
- Product code
- NVZ
- Decision date
- 2008-03-26
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- CHANGE TO THE WORKSTATION USED TO WELD THE CASE-TO-COVER SEAM JOINT ON MEDIUM RATE BATTERIES.
Current openFDA PMA Record#
- Device
- ENRHYTHM IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S087
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2008-03-26
- Decision code
- OK30
- Date received
- 2008-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE WORKSTATION USED TO WELD THE CASE-TO-COVER SEAM JOINT ON MEDIUM RATE BATTERIES.