PMA P970012S015
- Device
- MEDTRONIC. KAPPA 400 SERIES PACEMAKERS
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S015
- Product code
- DXY
- Decision date
- 2003-11-17
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.
Current openFDA PMA Record#
- Device
- MEDTRONIC. KAPPA 400 SERIES PACEMAKERS
- Applicant
- Medtronic, Inc.
- PMA number
- P970012
- Supplement
- S015
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2003-11-17
- Decision code
- APPR
- Date received
- 2003-08-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) MEDREL, JUNCOS, PUERTO RICO.