PMA P010015S117
- Device
- CONSULTA & SYNCRA CRT-P
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S117
- Product code
- OJX
- Decision date
- 2011-05-13
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- MULTIPLE MANUFACTURING CHANGES INCLUDING A COMPONENT TEST METHOD UPDATE, IMPLEMENTATION OF A NEW COMPONENT CLEANING PROCESS, AND IMPLEMENTATION OF ADDITIONAL LABELING EQUIPMENT AND SOFTWARE.
Current openFDA PMA Record#
- Device
- CONSULTA & SYNCRA CRT-P
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S117
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2011-05-13
- Decision code
- OK30
- Date received
- 2011-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MULTIPLE MANUFACTURING CHANGES INCLUDING A COMPONENT TEST METHOD UPDATE, IMPLEMENTATION OF A NEW COMPONENT CLEANING PROCESS, AND IMPLEMENTATION OF ADDITIONAL LABELING EQUIPMENT AND SOFTWARE.