PMA P980035S243
- Device
- 350 SERIES/ADAPTA/ENPULSE/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S243
- Product code
- NVZ
- Decision date
- 2011-10-21
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- CHANGE TO UPGRADE THE SOFTWARE VERSION FROM 1.5.1 TO 1.5.2 ON A LASER WELDER AT A SUPPLIER.
Current openFDA PMA Record#
- Device
- 350 SERIES/ADAPTA/ENPULSE/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S243
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2011-10-21
- Decision code
- OK30
- Date received
- 2011-09-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO UPGRADE THE SOFTWARE VERSION FROM 1.5.1 TO 1.5.2 ON A LASER WELDER AT A SUPPLIER.