PMA P980035S012
- Device
- MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S012
- Decision date
- 2001-10-24
- Approval order statement
- CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.
Current openFDA PMA Record#
- Device
- MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S012
- Decision date
- 2001-10-24
- Decision code
- OK30
- Date received
- 2001-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE CONTROLLED ENVIRONMENTAL AREA (CEA) FROM A CLASS 10,000 ENVIRONMENT TO A CLASS 100,000 ENVIRONMENT.