PMA P150012S002
- Device
- ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S002
- Product code
- LWP
- Decision date
- 2016-05-31
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Implementation of the following previously accepted manufacturing changes: 1) Removal of a plating process on the crystal oscillator component; 2) modifications to the crystal oscillator manufacturing process; 3) addition of an alternate supplier of a battery raw material; 4) addition of an alternate supplier of the power conductor component; 5) addition of an alternate supplier of the telemetry coils; 6) addition of an alternate supplier of capacitors; 7) addition of an automated visual inspection system for coil springs; 8) addition of an automated packaging line; and 9) vertical integration of the spring connector housing block.
Current openFDA PMA Record#
- Device
- ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S002
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-05-31
- Decision code
- OK30
- Date received
- 2016-05-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of the following previously accepted manufacturing changes: 1) Removal of a plating process on the crystal oscillator component; 2) modifications to the crystal oscillator manufacturing process; 3) addition of an alternate supplier of a battery raw material; 4) addition of an alternate supplier of the power conductor component; 5) addition of an alternate supplier of the telemetry coils; 6) addition of an alternate supplier of capacitors; 7) addition of an automated visual inspection system for coil springs; 8) addition of an automated packaging line; and 9) vertical integration of the spring connector housing block.