Accessory Stylet STR 0.013 45CM, Accessory Stylet STR 0.013 52CM,Accessory Stylet STR 0.013 59CM, Accessory Stylet LTPR
FDA premarket approval P150012/S074 · decided 2019-04-08
Approval details
- PMA number
- P150012
- Supplement
- S074
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Accessory Stylet STR 0.013 45CM, Accessory Stylet STR 0.013 52CM,Accessory Stylet STR 0.013 59CM, Accessory Stylet LTPR
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2019-03-13
- Decision date
- 2019-04-08
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Modifications to the frequency, equipment and method for monitoring airborne particulates.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.